PREPARE - Primary Prevention Parameters Evaluation - Full Text View

Sponsor:	Medtronic Cardiac Rhythm Disease Management
Collaborator:	Medtronic
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00279279

Purpose

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.

Condition	Intervention
Tachycardia, Ventricular Implantable Cardioverter Defibrillator (ICD) Fibrillation, Ventricular Syncope	Device: Implanted Device

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	PREPARE - Primary Prevention Parameters Evaluation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Fainting Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:

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 Outcome Measures:

Evaluate the percentage of inappropriate VT/VF detections
characterize the true incidence of VT/VF detections
therapy efficacy
time to first inappropriate VT/VF detection
incidence of untreated but monitored VT
programming changes
deaths and cardiovascular adverse event

Estimated Enrollment:	700
Study Start Date:	October 2003
Estimated Study Completion Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279279

Hide Study Locations

Locations

United States, Alabama

Birmingham, Alabama, United States
United States, Arizona

Phoenix, Arizona, United States

Mesa, Arizona, United States
United States, California

San Pablo, California, United States

San Diego, California, United States
United States, Delaware

Newark, Delaware, United States
United States, Florida

Jacksonville, Florida, United States

Ft. Lauderdale, Florida, United States

Merrit Island, Florida, United States
United States, Georgia

Columbus, Georgia, United States
United States, Illinois

Maywood, Illinois, United States

Rockford, Illinois, United States
United States, Kansas

Topeka, Kansas, United States
United States, Maine

Portland, Maine, United States
United States, Maryland

Silver Spring, Maryland, United States

Takoma Park, Maryland, United States
United States, Massachusetts

Boston, Massachusetts, United States
United States, Michigan

Royal Oak, Michigan, United States
United States, Minnesota

Minneapolis, Minnesota, United States
United States, New Jersey

Paterson, New Jersey, United States
United States, New York

Buffalo, New York, United States

New York, New York, United States
United States, Ohio

Elyria, Ohio, United States

Columbus, Ohio, United States
United States, Pennsylvania

Lancaster, Pennsylvania, United States

Bethlehem, Pennsylvania, United States
United States, South Carolina

Columbia, South Carolina, United States
United States, Tennessee

Nashville, Tennessee, United States
United States, Texas

Amarillo, Texas, United States
United States, Washington

Kirkland, Washington, United States
United States, West Virginia

Morgantown, West Virginia, United States
Puerto Rico

San Juan, Puerto Rico

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Medtronic

Investigators

Principal Investigator:

Bruce Wilkoff, M.D

The Cleveland Clinic

More Information

No publications provided by Medtronic Cardiac Rhythm Disease Management

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	223
Study First Received:	January 17, 2006
Last Updated:	October 25, 2006
ClinicalTrials.gov Identifier:	NCT00279279 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

Implantable cardioverter defibrillator (ICD)
Sudden Cardiac Death
Primary Prevention

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Tachycardia
Cardiovascular Diseases

Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on November 20, 2009