PREPARE - Primary Prevention Parameters Evaluation - Full Text View

Sponsors and Collaborators:	Medtronic Cardiac Rhythm Disease Management 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

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Fainting Pacemakers and Implantable Defibrillators

U.S. FDA Resources

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

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