## Protocol Section
### Identification Module
**NCT ID:** NCT00643279

**Brief Title:** Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)

**Official Title:** Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)

#### Organization Study ID Info
**ID:** COMPASS-HF
#### Organization
**Class:** INDUSTRY
**Full Name:** Medtronic Cardiac Rhythm and Heart Failure
### Status Module
#### Completion Date
**Date:** 2013-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-22

**Type:** ACTUAL

**Last Update Submit Date:** 2023-12-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2005-06

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-09-16

**Type:** ACTUAL

**Results First Submit Date:** 2019-06-11

**Results First Submit QC Date:** 2019-08-13

#### Start Date
**Date:** 2003-03

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2008-03-26
**Type:** ESTIMATED
**Study First Submit Date:** 2008-02-29
**Study First Submit QC Date:** 2008-03-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Medtronic Cardiac Rhythm and Heart Failure

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** COMPASS-HF was a prospective, two-arm, randomized (1:1), multi-center, parallel controlled study. The purpose of the randomized study was to test the safety of an implantable hemodynamic monitor (IHM) and pressure sensor lead. The premise of this study was to compare the effectiveness of a novel heart failure management strategy based on information obtained from the IHM system in reducing heart failure morbidity compared to a strategy based on standard medical care alone.

**Detailed Description:** COMPASS-HF was a prospective, two-arm, randomized (1:1), multi-center, parallel controlled study. The purpose of the randomized study was to test the safety of an implantable hemodynamic monitor (IHM) and pressure sensor lead. The premise of this study was to compare the effectiveness of a novel heart failure management strategy based on information obtained from the IHM system in reducing heart failure morbidity compared to a strategy based on standard medical care alone.

After baseline evaluation and verification that entrance criteria were met, all subjects were implanted with a Chronicle IHM and pressure sensor lead. Following successful implantation, subjects were randomized to either the CHRONICLE group or CONTROL group. Subjects randomized to the CHRONICLE group were managed using Chronicle, specifically trended RV and estimated PA pressure, heart rate and activity data, whereas subjects randomized to the CONTROL group were treated conventionally without the use of the Chronicle data. In the case that implantation was not successful, subjects were exited from the study if no procedure related adverse events were identified; procedure related adverse events were followed through to resolution before the subject were withdrawn from the study.

Subjects remained randomized until their six month clinic visit had been completed. Following the subject's six month visit, clinicians were granted access to the CONTROL subject's trended Chronicle data on the Chronicle website, and subjects were seen in the clinic for a protocol-required visit every six months until exit from the study.

### Conditions Module

**Conditions:**

- Heart Failure

**Keywords:**

- implantable hemodynamic monitor

- Intracardiac pressures

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 277

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects randomized to the CHRONICLE group were managed using data from an implantable hemodynamic monitoring (IHM) device, including trended right ventricular (RV) and estimated pulmonary arterial (PA) pressures, heart rate and activity data. The Chronicle IHM device does not provide therapy, but rather provides intracardiac diagnostic information about the patient which the physician can utilize to manage the patient and the patients heart failure.

**Intervention Names:**

- Device: Chronicle Implantable Hemodynamic Monitor

**Label:** CHRONICLE

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Subjects randomized to the CONTROL group implanted with the Chronicle implantable hemodynamic monitoring (IHM) device, but the intracardiac diagnostic information was blinded to both the patient and the physician during the randomized period of the study. Subjects were managed conventionally with standard of care. Physicians and patients have access to the intracardiac data after the randomized period of the study is over, at 6 months.

**Intervention Names:**

- Other: Standard of Care

**Label:** CONTROL

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CHRONICLE

**Description:** Surgical implantation of chronic ambulatory implantable hemodynamic monitoring (IHM) device and intracardiac pressure sensing lead. The implantable hemodynamic monitoring device captures intracardiac hemodynamic information about the patient including trended right ventricular (RV) and estimated pulmonary arterial (PA) pressures, heart rate and activity data. The IHM device does not provide therapy, but rather provides intracardiac diagnostic information about the patient which the physician can utilize to manage the patient and the patients heart failure.

**Name:** Chronicle Implantable Hemodynamic Monitor

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- CONTROL

**Description:** Surgical implantation of chronic ambulatory implantable hemodynamic monitoring (IHM) device and intracardiac pressure sensing lead, but physician and patient access to the intracardiac information provided by the device is restricted until the end of the randomized period of the study, at 6 months. Patients and patients heart failure are managed conventionally per standard of care.

**Name:** Standard of Care

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death, (3) results in the explant of any Chronicle IHM component, and/or (4) causes permanent loss of significant function of the implanted system.

Safety is defined as ≥ 80% of participants experiencing freedom from device related complications through 6 months.

**Measure:** Safety as Measured by the Percentage of Participants Free From System Related Complications Through 6 Months.

**Time Frame:** Within 6 months post-implant

**Description:** A pressure sensor failure was defined as a recognizable, abrupt, non-physiologic shift in pressure parameters.

Safety is defined as ≥ 90% of participants free from pressure sensor lead failure through 6 months.

**Measure:** Safety as Measured by the Percentage of Participants Free From Implantable Hemodynamic Monitor Pressure Related Sensor Lead Failures Through 6 Months.

**Time Frame:** Within 6 months post-implant

**Description:** Hospital equivalents (HE) were defined to include the following events:

1. Heart failure-related hospital admissions for 24 hours or longer
2. Heart failure-related emergency department visits and necessitates invasive treatment (e.g. IV diuretic administration).
3. Heart failure-related urgent visits and necessitates invasive treatment (e.g. IV diuretic administration).

**Measure:** Rate of Heart Failure-related Hospital Equivalents.

**Time Frame:** 6 Months post-implant

#### Secondary Outcomes

**Description:** Characterize total health care utilization, the total number of all-cause hospitalization, emergency department, and urgent care visits.

**Measure:** Health Care Utilization

**Time Frame:** 6 Months post-implant

**Description:** The number of days alive outside the hospital was calculated as the number of days of randomized follow-up minus the number of days hospitalized during the randomized follow-up period.

**Measure:** Days Hospitalization Free

**Time Frame:** 6 Months post-implant

**Description:** Worsened, Improved and Unchanged were defined as follows:

Worsened: Patient died, hospitalized for worsening heart failure, worsened NYHA Class Improved: Patient improved in NYHA Class Unchanged: Patient was neither improved nor worsened.

**Measure:** Clinical Composite Response of Either "Worsened", "Improved", or "Unchanged"

**Time Frame:** 6 Months post-implant

**Description:** Quality of life was measured by the Minnesota Living with Heart Failure (MLHF), a questionnaire with 21 questions and scored on a scale from 0 (good quality of life) to 105 (low quality of life).

Change in quality of life is defined as change from baseline to month 6. A participant must have completed a quality of life survey at the baseline visit and month 6 visit to be included in the analysis.

**Measure:** Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire

**Time Frame:** 6 Months post-implant

**Description:** New York Heart Association (NYHA) Classifications were defined as follows:

Class I - Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or angina.

Class II - Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina.

Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina.

Class IV - Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

**Measure:** New York Heart Association (NYHA) Class

**Time Frame:** 6 Months post-implant

**Description:** Patients completed six minute hall walk at baseline and 6 months. Outcome is change in hall walk distance from baseline to 6 months.

**Measure:** Distance Walked During a Six Minute Hall Walk

**Time Frame:** 6 Months post-implant

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subjects with heart failure classified as New York Heart Association (NYHA) Class III and IV
* Subject has been managed with standard medical therapy for heart failure (such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB), and beta-blocker for at least 3 months prior to the baseline evaluation
* Subject must have at least one heart failure-related hospitalization or emergency department visit requiring intravenous treatment within 6 months prior to baseline evaluation

Exclusion Criteria:

* Subjects who are likely to be transplanted within 6 months from randomization or will remain hospitalized until transplantation
* Subjects with severe COPD or restrictive airway disease (recommended FEV1 less than or equal to 1 liter or 50% predicted)
* Subjects who are on continuous positive inotropic therapy
* Subjects with known atrial or ventricular septal defects
* Subjects with mechanical right heart valves
* Subjects with stenotic tricuspid or pulmonary valves
* Subjects with a presently implanted non-compatible pacemaker or ICD
* Subjects with cardiac resynchronization therapy which has not achieved optimal programming for more than 3 months
* Subjects with a major cardiovascular event within 3 months prior to baseline evaluation
* Subjects with a severe non-cardiac condition limiting 6 month survival
* Subjects with a primary diagnosis of pulmonary artery hypertension
* Subjects with serum creatinine greater than or equal to 3.5 mg/dL or on chronic renal dialysis
* Subjects enrolled in concurrent studies that may confound the results of this study
* Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Birmingham

**Country:** United States

**Facility:** University of Alabama at Birmingham

**State:** Alabama

**Location 2:**

**City:** Loma Linda

**Country:** United States

**Facility:** Loma Linda University Medical Center

**State:** California

**Location 3:**

**City:** Los Angeles

**Country:** United States

**Facility:** UCLA Medical Center

**State:** California

**Location 4:**

**City:** Los Angeles

**Country:** United States

**Facility:** University of Southern California

**State:** California

**Location 5:**

**City:** Gainesville

**Country:** United States

**Facility:** University of Florida - Shands

**State:** Florida

**Location 6:**

**City:** Atlanta

**Country:** United States

**Facility:** Crawford LongHospital

**State:** Georgia

**Location 7:**

**City:** Springfield

**Country:** United States

**Facility:** Prairie Heart Institute

**State:** Illinois

**Location 8:**

**City:** Fort Wayne

**Country:** United States

**Facility:** Parkview Memorial Hospital

**State:** Indiana

**Location 9:**

**City:** Boston

**Country:** United States

**Facility:** New England Medical Center

**State:** Massachusetts

**Location 10:**

**City:** Saint Paul

**Country:** United States

**Facility:** St. Paul Heart

**State:** Minnesota

**Location 11:**

**City:** Kansas City

**Country:** United States

**Facility:** Mid America Heart Institute

**State:** Missouri

**Location 12:**

**City:** New Brunswick

**Country:** United States

**Facility:** Robert Wood Johnson Medical Center

**State:** New Jersey

**Location 13:**

**City:** Newark

**Country:** United States

**Facility:** Newark Beth Israel

**State:** New Jersey

**Location 14:**

**City:** New York

**Country:** United States

**Facility:** New York Presbyterian - Columbia

**State:** New York

**Location 15:**

**City:** Chapel Hill

**Country:** United States

**Facility:** Duke University

**State:** North Carolina

**Location 16:**

**City:** Cincinnati

**Country:** United States

**Facility:** University of Cincinnati

**State:** Ohio

**Location 17:**

**City:** Columbus

**Country:** United States

**Facility:** The Ohio State University

**State:** Ohio

**Location 18:**

**City:** Oklahoma City

**Country:** United States

**Facility:** Oklahoma Cardiovascular Associates

**State:** Oklahoma

**Location 19:**

**City:** Oklahoma City

**Country:** United States

**Facility:** University of Oklahoma

**State:** Oklahoma

**Location 20:**

**City:** Philadelphia

**Country:** United States

**Facility:** Hospital of the University of Pennsylvania

**State:** Pennsylvania

**Location 21:**

**City:** Philadelphia

**Country:** United States

**Facility:** Temple University Hospital

**State:** Pennsylvania

**Location 22:**

**City:** Pittsburgh

**Country:** United States

**Facility:** University of Pittsburgh

**State:** Pennsylvania

**Location 23:**

**City:** Charleston

**Country:** United States

**Facility:** Medical University of South Carolina

**State:** South Carolina

**Location 24:**

**City:** Germantown

**Country:** United States

**Facility:** Baptist Memorial Hospital

**State:** Tennessee

**Location 25:**

**City:** Nashville

**Country:** United States

**Facility:** St. Thomas Hospital

**State:** Tennessee

**Location 26:**

**City:** Houston

**Country:** United States

**Facility:** St. Luke's Episcopal Hospital/Texas Heart

**State:** Texas

**Location 27:**

**City:** Salt Lake City

**Country:** United States

**Facility:** LDS Hospital

**State:** Utah

**Location 28:**

**City:** Seattle

**Country:** United States

**Facility:** University of Washington Medical Center

**State:** Washington

#### Overall Officials

**Official 1:**

**Affiliation:** The University of Alabama at Birmingham

**Name:** Robert Bourge, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Zile MR, Adamson PB, Cho YK, Bennett TD, Bourge RC, Aaron MF, Aranda JM Jr, Abraham WT, Stevenson LW, Kueffer FJ. Hemodynamic factors associated with acute decompensated heart failure: part 1--insights into pathophysiology. J Card Fail. 2011 Apr;17(4):282-91. doi: 10.1016/j.cardfail.2011.01.010. Epub 2011 Feb 26.

**PMID:** 21440865

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Treatment

**Deaths Num Affected:** 13

**Deaths Num At Risk:** 134

**Description:** Physicians have access to device-based hemodynamic monitor information to guide patient management

**ID:** EG000

**Other Num Affected:** 15

**Other Num at Risk:** 134

**Serious Number Affected:** 79

**Serious Number At Risk:** 134

**Title:** Treatment

**Group ID:** EG001

**Title:** Control

**Deaths Num Affected:** 11

**Deaths Num At Risk:** 140

**Description:** Physicians do not have access to device-based hemodynamic monitor information to guide patient management

**ID:** EG001

**Other Num Affected:** 17

**Other Num at Risk:** 140

**Serious Number Affected:** 91

**Serious Number At Risk:** 140

**Title:** Control

**Frequency Threshold:** 1

#### Other Events

**Term:** Sustained VT

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Hypotension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Decompensated Heart Failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Angina

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Volume depletion/dehydration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Volume overload

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Decompensation of heart failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 35

**Num At Risk:** 134

**Num Events:** 57

**Group ID:** EG001

**Num Affected:** 43

**Num At Risk:** 140

**Num Events:** 68

**Term:** Volume overload

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 134

**Num Events:** 10

**Group ID:** EG001

**Num Affected:** 16

**Num At Risk:** 140

**Num Events:** 26

**Term:** Volume depletion/dehydration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 134

**Num Events:** 6

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 140

**Num Events:** 6

**Term:** Angina pectoris

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 8

**Num At Risk:** 134

**Num Events:** 8

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 140

**Num Events:** 1

**Term:** Cardiovascular procedure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 134

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 140

**Num Events:** 6

**Term:** Hypotension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 140

**Num Events:** 4

**Term:** Non-specific chest

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 134

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 140

**Num Events:** 4

**Term:** Non sustained VT

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 140

**Num Events:** 3

**Term:** Sustained VT

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 140

**Num Events:** 3

**Term:** Acute MI/Cardiac Arrest

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 134

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 140

**Num Events:** 3

**Term:** Atrial tachycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 134

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 140

**Num Events:** 1

**Term:** Paroxysmal atrial flutter/fibrillation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 134

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 140

**Num Events:** 1

**Term:** Persistent atrial flutter/fibrillation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 140

**Num Events:** 1

**Term:** Ventricular fibrillation/flutter

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 134

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 140

**Num Events:** 2

**Term:** Hypertension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 140

**Num Events:** 2

**Term:** Renal insufficiencies/failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 134

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 140

**Num Events:** 1

**Term:** Pneumonia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 140

**Num Events:** 1

**Term:** Ascites

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 134

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 140

**Num Events:** 1

**Term:** Stroke

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 140

**Num Events:** 1

**Term:** Electro Mechanical Dis-association

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 134

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 140

**Num Events:** 1

**Term:** Hyponatremia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 134

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 140

**Num Events:** 1

**Term:** Hypokalemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 134

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 140

**Num Events:** 2

**Term:** Elective Surgery

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

##### Stats

**Group ID:** EG000

**Num At Risk:** 134

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 140

**Num Events:** 1

**Term:** Inhalant Poisoning from Cleaning Agents

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

##### Stats

**Group ID:** EG000

**Num At Risk:** 134

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 140

**Num Events:** 1

**Term:** Sudden Cardiac Death

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 140

**Num Events:** 1

**Term:** Dyspnea/SOB

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 134

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 140

**Term:** Edema/weight gain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 140

**Term:** Lab value abnormalities

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 134

**Num Events:** 3

**Group ID:** EG001

**Num At Risk:** 140

**Term:** Worsening COPD

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 140

**Term:** Pulmonary edema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 140

**Term:** Anemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 140

**Term:** Urinary Tract Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 140

**Term:** Pleural effusion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 140

**Term:** Change in mental status

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 140

**Term:** Respiratory Failure/Arrest

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 140

**Term:** MRSA Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 140

**Term:** Sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 140

**Term:** Cardiac Transplant

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 140

**Term:** Peripheral Vascular Disease

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 140

**Term:** Allergic Reaction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 140

**Term:** Coronary Artery

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 134

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 140

**Time Frame:** 6 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 134

**Group ID:** BG001

**Value:** 140

**Group ID:** BG002

**Value:** 274

**Units:** Participants

### Group

**ID:** BG000

**Title:** Treatment

**Description:** Physicians have access to device-based hemodynamic monitor information to guide patient management

### Group

**ID:** BG001

**Title:** Control

**Description:** Physicians do not have access to device-based hemodynamic monitor information to guide patient management

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 14

**Value:** 58

#### Measurement

**Group ID:** BG001

**Spread:** 13

**Value:** 58

#### Measurement

**Group ID:** BG002

**Spread:** 14

**Value:** 58

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 59

#### Measurement

**Group ID:** BG001

**Value:** 50

#### Measurement

**Group ID:** BG002

**Value:** 109

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 75

#### Measurement

**Group ID:** BG001

**Value:** 90

#### Measurement

**Group ID:** BG002

**Value:** 165

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 134

#### Measurement

**Group ID:** BG001

**Value:** 140

#### Measurement

**Group ID:** BG002

**Value:** 274

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 112

#### Measurement

**Group ID:** BG001

**Value:** 122

#### Measurement

**Group ID:** BG002

**Value:** 234

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 40

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** New York Heart Association Class III (NYHA III)
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** New York Heart Association Class IV (NYHA IV)
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** dana.wigert@medtronic.com
**Organization:** Medtronic
**Phone:** 763-526-2802
**Title:** Dana Wigert
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 88.7
**CI Number of Sides:** ONE_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Survival estimate at 6-months
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** 6-month survival rate
**Parameter Value:** 91.5
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 98.9
**CI Number of Sides:** ONE_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** Survival estimate at 6-months
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** 6-month survival rate
**Parameter Value:** 100
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 277
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 274
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.51
- **Spread:** 
- **Upper Limit:** 0.78
- **Value:** 0.63
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.67
- **Spread:** 
- **Upper Limit:** 0.97
- **Value:** 0.81
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 218
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 255
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 164.1
- **Spread:** 
- **Upper Limit:** 177.6
- **Value:** 170.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 166.6
- **Spread:** 
- **Upper Limit:** 178.9
- **Value:** 172.7
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 56
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 48
**Title:** Improved
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 66
**Title:** Worsend
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26
**Title:** Unchanged
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -69
- **Spread:** 
- **Upper Limit:** 42
- **Value:** -12.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -73
- **Spread:** 
- **Upper Limit:** 89
- **Value:** -8.5
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** NYHA I
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 39
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 31
**Title:** NYHA II
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 70
**Title:** NYHA III
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
**Title:** NYHA IV
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 98.8
- **Upper Limit:** 
- **Value:** 6.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 114.2
- **Upper Limit:** 
- **Value:** -8.2
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death, (3) results in the explant of any Chronicle IHM component, and/or (4) causes permanent loss of significant function of the implanted system.

Safety is defined as ≥ 80% of participants experiencing freedom from device related complications through 6 months.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The analysis population for safety includes all subjects with an attempted implant of the Chronicle implantable hemodynamic monitoring device, including both successful implanted participants (274) and unsuccessful implanted participants (3). In total 277 participants were assessed for the safety objective.
**Reporting Status:** POSTED
**Time Frame:** Within 6 months post-implant
**Title:** Safety as Measured by the Percentage of Participants Free From System Related Complications Through 6 Months.
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** All subjects with an attempted implant of a Chronicle IHM.
**ID:** OG000
**Title:** All Subjects With Attempted Implant
#### Outcome Measure 2
**Description:** A pressure sensor failure was defined as a recognizable, abrupt, non-physiologic shift in pressure parameters.

Safety is defined as ≥ 90% of participants free from pressure sensor lead failure through 6 months.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Reporting Status:** POSTED
**Time Frame:** Within 6 months post-implant
**Title:** Safety as Measured by the Percentage of Participants Free From Implantable Hemodynamic Monitor Pressure Related Sensor Lead Failures Through 6 Months.
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** All subjects successfully implanted with a Chronicle IHM system
**ID:** OG000
**Title:** All Subjects Successfully Implanted
#### Outcome Measure 3
**Description:** Hospital equivalents (HE) were defined to include the following events:

1. Heart failure-related hospital admissions for 24 hours or longer
2. Heart failure-related emergency department visits and necessitates invasive treatment (e.g. IV diuretic administration).
3. Heart failure-related urgent visits and necessitates invasive treatment (e.g. IV diuretic administration).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** All randomized subjects
**Reporting Status:** POSTED
**Time Frame:** 6 Months post-implant
**Title:** Rate of Heart Failure-related Hospital Equivalents.
**Type:** PRIMARY
**Unit of Measure:** Events
##### Group
**Description:** Physicians have access to device-based hemodynamic monitor information to guide patient management
**ID:** OG000
**Title:** Treatment
##### Group
**Description:** Physicians do not have access to device-based hemodynamic monitor information to guide patient management
**ID:** OG001
**Title:** Control
#### Outcome Measure 4
**Description:** Characterize total health care utilization, the total number of all-cause hospitalization, emergency department, and urgent care visits.
**Parameter Type:** NUMBER
**Population Description:** All randomized subjects
**Reporting Status:** POSTED
**Time Frame:** 6 Months post-implant
**Title:** Health Care Utilization
**Type:** SECONDARY
**Unit of Measure:** Total number of events
##### Group
**Description:** Physicians have access to device-based hemodynamic monitor information to guide patient management
**ID:** OG000
**Title:** Treatment
##### Group
**Description:** Physicians do not have access to device-based hemodynamic monitor information to guide patient management
**ID:** OG001
**Title:** Control
#### Outcome Measure 5
**Description:** The number of days alive outside the hospital was calculated as the number of days of randomized follow-up minus the number of days hospitalized during the randomized follow-up period.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** All randomized subjects
**Reporting Status:** POSTED
**Time Frame:** 6 Months post-implant
**Title:** Days Hospitalization Free
**Type:** SECONDARY
**Unit of Measure:** Days
##### Group
**Description:** Physicians have access to device-based hemodynamic monitor information to guide patient management
**ID:** OG000
**Title:** Treatment
##### Group
**Description:** Physicians do not have access to device-based hemodynamic monitor information to guide patient management
**ID:** OG001
**Title:** Control
#### Outcome Measure 6
**Description:** Worsened, Improved and Unchanged were defined as follows:

Worsened: Patient died, hospitalized for worsening heart failure, worsened NYHA Class Improved: Patient improved in NYHA Class Unchanged: Patient was neither improved nor worsened.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** All randomized subjects
**Reporting Status:** POSTED
**Time Frame:** 6 Months post-implant
**Title:** Clinical Composite Response of Either "Worsened", "Improved", or "Unchanged"
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Physicians have access to device-based hemodynamic monitor information to guide patient management
**ID:** OG000
**Title:** Treatment
##### Group
**Description:** Physicians do not have access to device-based hemodynamic monitor information to guide patient management
**ID:** OG001
**Title:** Control
#### Outcome Measure 7
**Description:** Quality of life was measured by the Minnesota Living with Heart Failure (MLHF), a questionnaire with 21 questions and scored on a scale from 0 (good quality of life) to 105 (low quality of life).

Change in quality of life is defined as change from baseline to month 6. A participant must have completed a quality of life survey at the baseline visit and month 6 visit to be included in the analysis.
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Population Description:** All randomized subjects completing a quality of life survey at the baseline visit and month 6 visit
**Reporting Status:** POSTED
**Time Frame:** 6 Months post-implant
**Title:** Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire
**Type:** SECONDARY
**Unit of Measure:** Index score
##### Group
**Description:** Physicians have access to device-based hemodynamic monitor information to guide patient management
**ID:** OG000
**Title:** Treatment
##### Group
**Description:** Physicians do not have access to device-based hemodynamic monitor information to guide patient management
**ID:** OG001
**Title:** Control
#### Outcome Measure 8
**Description:** New York Heart Association (NYHA) Classifications were defined as follows:

Class I - Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or angina.

Class II - Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina.

Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina.

Class IV - Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** All randomized subjects with NYHA assessment completed at baseline and at 6 months were included in the analysis
**Reporting Status:** POSTED
**Time Frame:** 6 Months post-implant
**Title:** New York Heart Association (NYHA) Class
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Physicians have access to device-based hemodynamic monitor information to guide patient management
**ID:** OG000
**Title:** Treatment
##### Group
**Description:** Physicians do not have access to device-based hemodynamic monitor information to guide patient management
**ID:** OG001
**Title:** Control
#### Outcome Measure 9
**Description:** Patients completed six minute hall walk at baseline and 6 months. Outcome is change in hall walk distance from baseline to 6 months.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All randomized patients completing a hall walk at baseline and 6 months.
**Reporting Status:** POSTED
**Time Frame:** 6 Months post-implant
**Title:** Distance Walked During a Six Minute Hall Walk
**Type:** SECONDARY
**Unit of Measure:** Meters
##### Group
**Description:** Physicians have access to device-based hemodynamic monitor information to guide patient management
**ID:** OG000
**Title:** Treatment
##### Group
**Description:** Physicians do not have access to device-based hemodynamic monitor information to guide patient management
**ID:** OG001
**Title:** Control
### Participant Flow Module
#### Group
**Description:** Physicians have access to device-based hemodynamic monitor information to guide patient management
**ID:** FG000
**Title:** Treatment
#### Group
**Description:** Physicians do not have access to device-based hemodynamic monitor information to guide patient management
**ID:** FG001
**Title:** Control
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 13
###### Reason
**Group ID:** FG001
**Number of Subjects:** 11
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 134
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 140
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 118
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 127
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 16
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 13
**Pre-Assignment Details:** Subjects were required to have a successful implant of the Chronicle® device prior to randomization. 277 subjects had an attempted implant, with 274 successfully implanted and randomized. 3 subjects had unsuccessful implant attempts and were exited prior to randomization.
**Recruitment Details:** Recruitment began on March 13, 2003 and ended on November 16, 2004. All subjects were exited from the study on April 8, 2013. Twenty-nine US clinical centers participated in the COMPASS-HF study.
**Has Results:** True