## Protocol Section
### Identification Module
**NCT ID:** NCT00279279

**Brief Title:** PREPARE - Primary Prevention Parameters Evaluation

**Official Title:** PREPARE - Primary Prevention Parameters Evaluation

#### Organization Study ID Info
**ID:** 223
#### Organization
**Class:** INDUSTRY
**Full Name:** Medtronic Cardiac Rhythm and Heart Failure
### Status Module
#### Completion Date
**Date:** 2006-05

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2006-10-26

**Type:** ESTIMATED

**Last Update Submit Date:** 2006-10-25

**Overall Status:** COMPLETED

#### Start Date
**Date:** 2003-10

**Status Verified Date:** 2006-10

#### Study First Post Date
**Date:** 2006-01-19
**Type:** ESTIMATED
**Study First Submit Date:** 2006-01-17
**Study First Submit QC Date:** 2006-01-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Medtronic

#### Lead Sponsor

**Class:** INDUSTRY

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

### Description Module

**Brief Summary:** The purpose of this study is to test specific device programming in patients without a previous history of a life-threatening, abnormally fast heartbeat who are implanted with a Medtronic ICD (Implantable Cardioconverter Defibrillator) or ICD with CRT (Cardiac Resynchronozation Therapy) device. The information learned from this study could be used to guide physicians in future ICD or CRT device programming.

### Conditions Module

**Conditions:**

- Tachycardia, Ventricular

- Implantable Cardioverter Defibrillator (ICD)

- Fibrillation, Ventricular

- Syncope

**Keywords:**

- Implantable cardioverter defibrillator (ICD)

- Sudden Cardiac Death

- Primary Prevention

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 700

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Implanted Device

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Demonstrate that patients programmed using a prescribed set of parameters have a lower rate of cardiac syncope, symptoms of fast heart rate, VT/VF events and cardioversion or defibrillation shocks compared to patients programmed per physician discretion

#### Secondary Outcomes

**Measure:** Evaluate the percentage of inappropriate VT/VF detections

**Measure:** characterize the true incidence of VT/VF detections

**Measure:** therapy efficacy

**Measure:** time to first inappropriate VT/VF detection

**Measure:** incidence of untreated but monitored VT

**Measure:** programming changes

**Measure:** deaths and cardiovascular adverse event

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Patient is a candidate for a non-replacement Medtronic ICD device from the Marquis family or has had a non-replacement Medtronic Marquis based ICD system implanted within the previous 6 months and has not had any appropriately treated spontaneous VT/VF episodes during that time.

Exclusion Criteria:

Patient has history of spontaneous sustained symptomatic ventricular arrhythmias.

If patient has had an electrophysiology test in the past, and has sustained inducible VT \<180 bpm.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Birmingham

**Country:** United States

**State:** Alabama

**Location 2:**

**City:** Mesa

**Country:** United States

**State:** Arizona

**Location 3:**

**City:** Phoenix

**Country:** United States

**State:** Arizona

**Location 4:**

**City:** San Diego

**Country:** United States

**State:** California

**Location 5:**

**City:** San Pablo

**Country:** United States

**State:** California

**Location 6:**

**City:** Newark

**Country:** United States

**State:** Delaware

**Location 7:**

**City:** Ft. Lauderdale

**Country:** United States

**State:** Florida

**Location 8:**

**City:** Jacksonville

**Country:** United States

**State:** Florida

**Location 9:**

**City:** Merrit Island

**Country:** United States

**State:** Florida

**Location 10:**

**City:** Columbus

**Country:** United States

**State:** Georgia

**Location 11:**

**City:** Maywood

**Country:** United States

**State:** Illinois

**Location 12:**

**City:** Rockford

**Country:** United States

**State:** Illinois

**Location 13:**

**City:** Topeka

**Country:** United States

**State:** Kansas

**Location 14:**

**City:** Portland

**Country:** United States

**State:** Maine

**Location 15:**

**City:** Silver Spring

**Country:** United States

**State:** Maryland

**Location 16:**

**City:** Takoma Park

**Country:** United States

**State:** Maryland

**Location 17:**

**City:** Boston

**Country:** United States

**State:** Massachusetts

**Location 18:**

**City:** Royal Oak

**Country:** United States

**State:** Michigan

**Location 19:**

**City:** Minneapolis

**Country:** United States

**State:** Minnesota

**Location 20:**

**City:** Paterson

**Country:** United States

**State:** New Jersey

**Location 21:**

**City:** Buffalo

**Country:** United States

**State:** New York

**Location 22:**

**City:** New York

**Country:** United States

**State:** New York

**Location 23:**

**City:** Columbus

**Country:** United States

**State:** Ohio

**Location 24:**

**City:** Elyria

**Country:** United States

**State:** Ohio

**Location 25:**

**City:** Bethlehem

**Country:** United States

**State:** Pennsylvania

**Location 26:**

**City:** Lancaster

**Country:** United States

**State:** Pennsylvania

**Location 27:**

**City:** Columbia

**Country:** United States

**State:** South Carolina

**Location 28:**

**City:** Nashville

**Country:** United States

**State:** Tennessee

**Location 29:**

**City:** Amarillo

**Country:** United States

**State:** Texas

**Location 30:**

**City:** Kirkland

**Country:** United States

**State:** Washington

**Location 31:**

**City:** Morgantown

**Country:** United States

**State:** West Virginia

**Location 32:**

**City:** San Juan

**Country:** Puerto Rico

#### Overall Officials

**Official 1:**

**Affiliation:** The Cleveland Clinic

**Name:** Bruce Wilkoff, M.D

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** van Gelder IC, Phan HM, Wilkoff BL, Brown ML, Rogers T, Peterson BJ, Birgersdotter-Green UM. Prognostic significance of atrial arrhythmias in a primary prevention ICD population. Pacing Clin Electrophysiol. 2011 Sep;34(9):1070-9. doi: 10.1111/j.1540-8159.2011.03124.x. Epub 2011 May 23.

**PMID:** 21605131

**Citation:** Wilkoff BL, Williamson BD, Stern RS, Moore SL, Lu F, Lee SW, Birgersdotter-Green UM, Wathen MS, Van Gelder IC, Heubner BM, Brown ML, Holloman KK; PREPARE Study Investigators. Strategic programming of detection and therapy parameters in implantable cardioverter-defibrillators reduces shocks in primary prevention patients: results from the PREPARE (Primary Prevention Parameters Evaluation) study. J Am Coll Cardiol. 2008 Aug 12;52(7):541-50. doi: 10.1016/j.jacc.2008.05.011.

**PMID:** 18687248

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000075224

- Term: Cardiac Conduction System Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000014474

- Term: Unconsciousness

- ID: D000003244

- Term: Consciousness Disorders

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M6845

- Name: Death

- Relevance: LOW

- As Found: Unknown

- ID: M16384

- Name: Tachycardia

- Relevance: HIGH

- As Found: Tachycardia

- ID: M19488

- Name: Tachycardia, Ventricular

- Relevance: HIGH

- As Found: Tachycardia, Ventricular

- ID: M16353

- Name: Syncope

- Relevance: HIGH

- As Found: Syncope

- ID: M19118

- Name: Death, Sudden, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M17439

- Name: Ventricular Fibrillation

- Relevance: HIGH

- As Found: Fibrillation, Ventricular

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M1472

- Name: Cardiac Conduction System Disease

- Relevance: LOW

- As Found: Unknown

- ID: M17224

- Name: Unconsciousness

- Relevance: LOW

- As Found: Unknown

- ID: M6468

- Name: Consciousness Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T4437

- Name: Paroxysmal Ventricular Fibrillation

- Relevance: HIGH

- As Found: Fibrillation, Ventricular

### Condition Browse Module - Meshes

- ID: D000013575

- Term: Syncope

- ID: D000013610

- Term: Tachycardia

- ID: D000017180

- Term: Tachycardia, Ventricular

- ID: D000014693

- Term: Ventricular Fibrillation

### Misc Info Module

- Version Holder: 2024-05-24
