## Protocol Section
### Identification Module
**NCT ID:** NCT01112579

**Acronym:** DEFEAT-HF

**Brief Title:** Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure

**Official Title:** Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure

#### Organization Study ID Info
**ID:** DEFEAT-HF
#### Organization
**Class:** INDUSTRY
**Full Name:** Medtronic Cardiac Rhythm and Heart Failure
### Status Module
#### Completion Date
**Date:** 2015-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-10-29

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-10-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-01

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2015-10-29

**Type:** ESTIMATED

**Results First Submit Date:** 2015-10-01

**Results First Submit QC Date:** 2015-10-01

#### Start Date
**Date:** 2010-04

**Status Verified Date:** 2015-10

#### Study First Post Date
**Date:** 2010-04-28
**Type:** ESTIMATED
**Study First Submit Date:** 2010-04-16
**Study First Submit QC Date:** 2010-04-27
### 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:** The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure.

### Conditions Module

**Conditions:**

- Heart Failure

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 81

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: Medtronic PrimeADVANCED Neurostimulator

**Label:** Treatment

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Device: Medtronic PrimeADVANCED Neurostimulator

**Label:** Control

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment

**Description:** Heart failure therapy

**Name:** Medtronic PrimeADVANCED Neurostimulator

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Control

**Description:** Medical management

**Name:** Medtronic PrimeADVANCED Neurostimulator

**Other Names:**

- Medical management

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to the Control Arm.

**Time Frame:** Baseline and 6 months

#### Secondary Outcomes

**Measure:** Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months

**Time Frame:** Baseline and 6 Months

**Measure:** Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months

**Time Frame:** Baseline and 6 Months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Left Ventricular Ejection Fraction (LVEF) of 35 percent or less
* New York Heart Association (NYHA) functional Class III at time of screening
* QRS duration less than 120 milliseconds (ms)
* Left Ventricular End Diastolic Diameter (LVEDD) of 55 millimeters (mm) to 80 mm as determined by echocardiography within the past 6 months
* Receiving stable optimal medical therapy for heart failure prior to enrollment
* Serum creatinine less than or equal to 3.0 milligrams per deciliter (mg/dL)
* 18 years of age or older
* Willing and able to comply with study procedures
* Expected lifespan greater than 12 months beyond study enrollment as assessed by physician

Exclusion Criteria:

* Interruption of thromboprophylaxis (e.g., heparin, LMWH, warfarin, aspirin, dabigatran, clopidogrel) would pose an unacceptable health risk (e.g., patient with an abnormal bleeding time), as determined by physician
* Polyneuropathy
* Requires diathermy including shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy
* Unable to perform an exercise capacity test
* Pregnant or planning to become pregnant during this study
* Currently enrolled or plans to enroll in another investigational device or drug study that may confound the results of this study
* Had Coronary Artery Bypass Graft/Percutaneous Coronary Intervention/Bare Metal Stent (CABG/PCI/BMS) procedures within the past 90 days
* Had a heart transplant
* Has complete heart block
* Had Acute Coronary Syndrome within the past 90 days
* Has congenital heart disease with significant hemodynamic shunting
* Has chemotherapy-induced heart failure
* Has reversible cardiomyopathy
* Has severe mitral regurgitation (greater than 60 percent regurgitant fraction or greater than 0.3 centimeters squared (cm2) regurgitant orifice area)
* Has diagnosed unstable angina pectoris
* Has unstable coronary artery disease
* Has a Cardiac Resynchronization Therapy (CRT) device implanted and is receiving CRT therapy
* Has a non-Medtronic Implantable Cardioverter Defibrillator (ICD), pacemaker, or any non-transvenous defibrillation lead
* Has a Medtronic ICD whose sensing threshold cannot be programmed to 0.3mV or greater
* Has an existing neurostimulator

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Miami

**Country:** United States

**State:** Florida

**Location 2:**

**City:** Indianapolis

**Country:** United States

**State:** Indiana

**Location 3:**

**City:** Allentown

**Country:** United States

**State:** Pennsylvania

**Location 4:**

**City:** Philadelphia

**Country:** United States

**State:** Pennsylvania

**Location 5:**

**City:** Burlington

**Country:** United States

**State:** Vermont

**Location 6:**

**City:** Spokane

**Country:** United States

**State:** Washington

**Location 7:**

**City:** Vancouver

**Country:** Canada

**State:** British Columbia

**Location 8:**

**City:** Victoria

**Country:** Canada

**State:** British Columbia

**Location 9:**

**City:** Prague

**Country:** Czech Republic

**Location 10:**

**City:** Berlin

**Country:** Germany

**Location 11:**

**City:** Herne

**Country:** Germany

**Location 12:**

**City:** Rome

**Country:** Italy

**Location 13:**

**City:** Groningen

**Country:** Netherlands

**Location 14:**

**City:** Maastricht

**Country:** Netherlands

**Location 15:**

**City:** Zwolle

**Country:** Netherlands

**Location 16:**

**City:** Cape Town

**Country:** South Africa

**Location 17:**

**City:** Johannesburg

**Country:** South Africa

**Location 18:**

**City:** Gothenburg

**Country:** Sweden

**Location 19:**

**City:** Stockholm

**Country:** Sweden

#### Overall Officials

**Official 1:**

**Affiliation:** Krannert Institute of Cardiology

**Name:** Douglas P Zipes, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Charite Universitatsmedizin Berlin - Campus Charite Mitte

**Name:** Heinz Theres, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Zipes DP, Neuzil P, Theres H, Caraway D, Mann DL, Mannheimer C, Van Buren P, Linde C, Linderoth B, Kueffer F, Sarazin SA, DeJongste MJL; DEFEAT-HF Trial Investigators. Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Systolic Heart Failure: The DEFEAT-HF Study. JACC Heart Fail. 2016 Feb;4(2):129-136. doi: 10.1016/j.jchf.2015.10.006. Epub 2015 Dec 9. Erratum In: JACC Heart Fail. 2018 Jun;6(6):542.

**PMID:** 26682789

## 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

- Abbrev: Rare

- Name: Rare Diseases

### 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

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- 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

**Description:** Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy

**ID:** EG000

**Other Num Affected:** 19

**Other Num at Risk:** 42

**Serious Number Affected:** 30

**Serious Number At Risk:** 42

**Title:** Treatment

**Group ID:** EG001

**Title:** Control

**Description:** Medtronic PrimeADVANCED Neurostimulator: Medical management

**ID:** EG001

**Other Num Affected:** 12

**Other Num at Risk:** 24

**Serious Number Affected:** 16

**Serious Number At Risk:** 24

**Title:** Control

**Frequency Threshold:** 5

#### Other Events

**Term:** Decompensated Heart Failure

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Dyspepsia

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Adverse Drug Reaction

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Device Stimulation Issue

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Fatigue

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Bronchitis

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Osteoarthritis

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Pain in Extremity

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Dizziness

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Dyspnoea

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

**Source Vocabulary:** 

**Term:** Skin Reaction

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Orthostatic Hypotension

**Organ System:** Vascular disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Anaemia

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Atrial Fibrillation

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Atrial Tachycardia

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Bradycardia

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Cardiac Failure Acute

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Cardiac Failure Congestive

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Cardiac Perforation

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Cardiogenic Shock

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 24

**Num Events:** 2

**Term:** Decompensated Heart Failure

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 16

**Num At Risk:** 42

**Num Events:** 33

**Group ID:** EG001

**Num Affected:** 7

**Num At Risk:** 24

**Num Events:** 15

**Term:** Pericardial Effusion

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Ventricular Arrhythmia

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Ventricular Fibrillation

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Ventricular Tachycardia

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 24

**Num Events:** 3

**Term:** Abdominal Wall Haematoma

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Ascites

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Gastritis

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Gastrointestinal Haemorrhage

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Haemorrhoidal Haemorrhage

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Pancreatic Cyst

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Pancreatitis

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Vomiting

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 2

**Term:** Adverse Drug Reaction

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Arterial Restenosis

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Chest Pain

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 42

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Death

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Device Extrusion

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Device Inappropriate Shock Delivery

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Device Lead Damage

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Lead Dislodgement

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 42

**Num Events:** 3

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Sudden Cardiac Death

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 42

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Sudden Death

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Ischaemic Hepatitis

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Bronchopneumonia

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Clostridium Difficile Colitis

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 3

**Term:** Endocarditis

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Gastroenteritis

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Implant Site Infection

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Pericarditis Infective

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Pneumonia

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 42

**Num Events:** 6

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 24

**Num Events:** 3

**Term:** Pyleonephritis

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Respiratory Tract Infection

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Septic Shock

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Upper Respiratory Tract Infection

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Urinary Tract Infection

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Femur Fracture

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Toxicity to Various Agents

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** International Normalised Ratio Increased

**Organ System:** Investigations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Dehydration

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Gout

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Hypoglycaemia

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Hypokalaemia

**Organ System:** Metabolism and nutrition disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 2

**Term:** Bursitis

**Organ System:** Musculoskeletal and connective tissue disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Gouty Arthritis

**Organ System:** Musculoskeletal and connective tissue disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Gallbladder Neoplasm

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Rectosigmoid Cancer Metastatic

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Cerebrovascular Accident

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Epilepsy

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Loss of Consiousness

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Presyncope

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Sciatica

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Syncope

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Renal Failure

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Renal Failure Acute

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Renal Failure Chronic

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Endometrial Atrophy

**Organ System:** Reproductive system and breast disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Apnoea

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

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Pneumonitis

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Respiratory Depression

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Dry Gangrene

**Organ System:** Skin and subcutaneous tissue disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Aortic Dissection

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Circulatory Collapse

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Haematoma

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Hypotension

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 42

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 24

**Term:** Peripheral Arterial Occlusive Disease

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 42

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 24

**Num Events:** 1

**Term:** Thrombosis

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 42

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 24

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 42

**Group ID:** BG001

**Value:** 24

**Group ID:** BG002

**Value:** 66

**Units:** Participants

### Group

**ID:** BG000

**Title:** Treatment

**Description:** Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy

### Group

**ID:** BG001

**Title:** Control

**Description:** Medtronic PrimeADVANCED Neurostimulator: Medical management

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 11

**Value:** 58

#### Measurement

**Group ID:** BG001

**Spread:** 11

**Value:** 66

#### Measurement

**Group ID:** BG002

**Spread:** 12

**Value:** 61

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 14

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 32

#### Measurement

**Group ID:** BG001

**Value:** 20

#### Measurement

**Group ID:** BG002

**Value:** 52

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 3

**Class Title:** Canada

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 22

**Class Title:** Czech Republic

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 14

**Class Title:** Netherlands

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 9

**Class Title:** Sweden

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 3

#### Measurement

**Group ID:** BG002

**Value:** 12

**Class Title:** United States

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 3

**Class Title:** Italy

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Class Title:** South Africa

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Class Title:** Germany

**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:** Randomized participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** MedtronicCRMtrials@medtronic.com
**Organization:** Medtronic Cardiac Rhythm and Heart Failure
**Phone:** 1-800-328-2518
**Title:** DEFEAT-HF Clinical Team
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -2.0
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 14.9
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.3
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 6.4
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** -845.8
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 633.6
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.79
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -106.1
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** -1.6
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 3.2
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.93
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.8
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 16.0
- **Upper Limit:** 
- **Value:** 2.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 14.9
- **Upper Limit:** 
- **Value:** -3.6
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 994.0
- **Upper Limit:** 
- **Value:** -32.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1468.0
- **Upper Limit:** 
- **Value:** 73.8
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.1
- **Upper Limit:** 
- **Value:** 0.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.3
- **Upper Limit:** 
- **Value:** -0.2
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline and 6 months
**Title:** Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to the Control Arm.
**Type:** PRIMARY
**Unit of Measure:** mL/m2
##### Group
**Description:** Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
**ID:** OG000
**Title:** Treatment
##### Group
**Description:** Medtronic PrimeADVANCED Neurostimulator: Medical management
**ID:** OG001
**Title:** Control
#### Outcome Measure 2
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline and 6 Months
**Title:** Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months
**Type:** SECONDARY
**Unit of Measure:** pg/mL
##### Group
**Description:** Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
**ID:** OG000
**Title:** Treatment
##### Group
**Description:** Medtronic PrimeADVANCED Neurostimulator: Medical management
**ID:** OG001
**Title:** Control
#### Outcome Measure 3
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline and 6 Months
**Title:** Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months
**Type:** SECONDARY
**Unit of Measure:** mL/kg/min
##### Group
**Description:** Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
**ID:** OG000
**Title:** Treatment
##### Group
**Description:** Medtronic PrimeADVANCED Neurostimulator: Medical management
**ID:** OG001
**Title:** Control
### Participant Flow Module
#### Group
**Description:** Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
**ID:** FG000
**Title:** Treatment
#### Group
**Description:** Medtronic PrimeADVANCED Neurostimulator: Medical management
**ID:** FG001
**Title:** Control
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Missed Visit
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 42
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 24
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 41
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 21
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
**Has Results:** True