PREPARE - Primary Prevention Parameters Evaluation
1 other identifier
interventional
700
2 countries
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2003
Typical duration for not_applicable
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 17, 2006
CompletedFirst Posted
Study publicly available on registry
January 19, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedOctober 26, 2006
October 1, 2006
January 17, 2006
October 25, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (7)
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
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic Cardiac Rhythm and Heart Failurelead
- Medtroniccollaborator
Study Sites (32)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Mesa, Arizona, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
San Pablo, California, United States
Unknown Facility
Newark, Delaware, United States
Unknown Facility
Fort Lauderdale, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Merrit Island, Florida, United States
Unknown Facility
Columbus, Georgia, United States
Unknown Facility
Maywood, Illinois, United States
Unknown Facility
Rockford, Illinois, United States
Unknown Facility
Topeka, Kansas, United States
Unknown Facility
Portland, Maine, United States
Unknown Facility
Silver Spring, Maryland, United States
Unknown Facility
Takoma Park, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Royal Oak, Michigan, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
Paterson, New Jersey, United States
Unknown Facility
Buffalo, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Elyria, Ohio, United States
Unknown Facility
Bethlehem, Pennsylvania, United States
Unknown Facility
Lancaster, Pennsylvania, United States
Unknown Facility
Columbia, South Carolina, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Amarillo, Texas, United States
Unknown Facility
Kirkland, Washington, United States
Unknown Facility
Morgantown, West Virginia, United States
Unknown Facility
San Juan, Puerto Rico
Related Publications (2)
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: 21605131DERIVEDWilkoff 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: 18687248DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruce Wilkoff, M.D
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 17, 2006
First Posted
January 19, 2006
Study Start
October 1, 2003
Study Completion
May 1, 2006
Last Updated
October 26, 2006
Record last verified: 2006-10