PREPARE - Primary Prevention Parameters Evaluation - Tabular View

Tracking Information

First Received Date ^ICMJE

January 17, 2006

Last Updated Date

October 25, 2006

Start Date ^ICMJE

October 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00279279 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

PREPARE - Primary Prevention Parameters Evaluation

Official Title ^ICMJE

PREPARE - Primary Prevention Parameters Evaluation

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Tachycardia, Ventricular
Implantable Cardioverter Defibrillator (ICD)
Fibrillation, Ventricular
Syncope

Intervention ^ICMJE

Device: Implanted Device

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

700

Completion Date

May 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Puerto Rico

Administrative Information

NCT ID ^ICMJE

NCT00279279

Responsible Party

Study ID Numbers ^ICMJE

223

Study Sponsor ^ICMJE

Medtronic Cardiac Rhythm Disease Management

Collaborators ^ICMJE

Medtronic

Investigators ^ICMJE

Principal Investigator:

Bruce Wilkoff, M.D

The Cleveland Clinic

Information Provided By

Medtronic Cardiac Rhythm Disease Management

Verification Date

October 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP