NCT00279279|Completed
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Sponsor study identifier
interventional
700
2 countries
32
Study Start
October 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2003
Date type not reportedThis date has not been verified as actual or estimated.
January 17, 2006
Actual (reported)January 19, 2006
Actual (reported)May 2006
Date type not reportedThis date has not been verified as actual or estimated.
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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Birmingham, Alabama, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
San Diego, California, United States
San Pablo, California, United States
Newark, Delaware, United States
Fort Lauderdale, Florida, United States
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.
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.
Bruce Wilkoff, M.D
The Cleveland Clinic
First Submitted
January 17, 2006
First Posted
January 19, 2006
Study Start
October 2003
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
May 2006
Date type not reportedContact the study team to confirm eligibility.
Jacksonville, Florida, United States
Merrit Island, Florida, United States
Columbus, Georgia, United States
Maywood, Illinois, United States
Rockford, Illinois, United States
Topeka, Kansas, United States
Portland, Maine, United States
Silver Spring, Maryland, United States
Takoma Park, Maryland, United States
Boston, Massachusetts, United States
Royal Oak, Michigan, United States
Minneapolis, Minnesota, United States
Paterson, New Jersey, United States
Buffalo, New York, United States
New York, New York, United States
Columbus, Ohio, United States
Elyria, Ohio, United States
Bethlehem, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Columbia, South Carolina, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Kirkland, Washington, United States
Morgantown, West Virginia, United States
San Juan, Puerto Rico
This date has not been verified as actual or estimated.
Last Updated
October 26, 2006
Record last verified: 2006-10
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Source: ClinicalTrials.gov.
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