Clinical trial NCT00279279: PREPARE - Primary Prevention Parameters Evaluation
Official title: PREPARE - Primary Prevention Parameters Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tachycardia, Ventricular
Implantable Cardioverter Defibrillator (ICD)
Fibrillation, Ventricular
Syncope
Keywords: Implantable cardioverter defibrillator (ICD)
Sudden Cardiac Death
Primary Prevention
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2006-01-19
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: 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:
measure: Evaluate the percentage of inappropriate VT/VF detections
measure: characterize the true incidence of VT/VF detections
measure: therapy efficacy
measure: time to first inappropriate VT/VF detection
measure: incidence of untreated but monitored VT
measure: programming changes
measure: deaths and cardiovascular adverse event
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: San Diego
country: United States
state: California
city: San Pablo
country: United States
state: California
city: Newark
country: United States
state: Delaware
city: Ft. Lauderdale
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Merrit Island
country: United States
state: Florida
city: Columbus
country: United States
state: Georgia
city: Maywood
country: United States
state: Illinois
city: Rockford
country: United States
state: Illinois
city: Topeka
country: United States
state: Kansas
city: Portland
country: United States
state: Maine
city: Silver Spring
country: United States
state: Maryland
city: Takoma Park
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Royal Oak
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Paterson
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Elyria
country: United States
state: Ohio
city: Bethlehem
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Kirkland
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
city: San Juan
country: Puerto Rico
Study officials:
affiliation: The Cleveland Clinic
name: Bruce Wilkoff, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.