Back to resultsPREPARE - Primary Prevention Parameters Evaluation
Primary Purpose
Tachycardia, Ventricular, Implantable Cardioverter Defibrillator (ICD), Fibrillation, Ventricular
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Implanted Device
Sponsored by
About this trial
This is an interventional prevention trial for Tachycardia, Ventricular focused on measuring Implantable cardioverter defibrillator (ICD), Sudden Cardiac Death, Primary Prevention
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.
Sites / Locations
Outcomes
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
Full Information
NCT ID
NCT00279279
First Posted
January 17, 2006
Last Updated
October 25, 2006
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00279279
Brief Title
PREPARE - Primary Prevention Parameters Evaluation
Official Title
PREPARE - Primary Prevention Parameters Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia, Ventricular, Implantable Cardioverter Defibrillator (ICD), Fibrillation, Ventricular, Syncope
Keywords
Implantable cardioverter defibrillator (ICD), Sudden Cardiac Death, Primary Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
700 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Implanted Device
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Evaluate the percentage of inappropriate VT/VF detections
Title
characterize the true incidence of VT/VF detections
Title
therapy efficacy
Title
time to first inappropriate VT/VF detection
Title
incidence of untreated but monitored VT
Title
programming changes
Title
deaths and cardiovascular adverse event
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Wilkoff, M.D
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Mesa
State/Province
Arizona
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
San Diego
State/Province
California
Country
United States
City
San Pablo
State/Province
California
Country
United States
City
Newark
State/Province
Delaware
Country
United States
City
Ft. Lauderdale
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Merrit Island
State/Province
Florida
Country
United States
City
Columbus
State/Province
Georgia
Country
United States
City
Maywood
State/Province
Illinois
Country
United States
City
Rockford
State/Province
Illinois
Country
United States
City
Topeka
State/Province
Kansas
Country
United States
City
Portland
State/Province
Maine
Country
United States
City
Silver Spring
State/Province
Maryland
Country
United States
City
Takoma Park
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Royal Oak
State/Province
Michigan
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
Paterson
State/Province
New Jersey
Country
United States
City
Buffalo
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Elyria
State/Province
Ohio
Country
United States
City
Bethlehem
State/Province
Pennsylvania
Country
United States
City
Lancaster
State/Province
Pennsylvania
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Amarillo
State/Province
Texas
Country
United States
City
Kirkland
State/Province
Washington
Country
United States
City
Morgantown
State/Province
West Virginia
Country
United States
City
San Juan
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
21605131
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.
Results Reference
derived
PubMed Identifier
18687248
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.
Results Reference
derived
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PREPARE - Primary Prevention Parameters Evaluation
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