PREPARE - Primary Prevention Parameters Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00279279
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : October 26, 2006
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure

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.

Condition or disease Intervention/treatment Phase
Tachycardia, Ventricular Implantable Cardioverter Defibrillator (ICD) Fibrillation, Ventricular Syncope Device: Implanted Device Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 700 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PREPARE - Primary Prevention Parameters Evaluation
Study Start Date : October 2003
Study Completion Date : May 2006

Primary Outcome Measures :
  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 Outcome Measures :
  1. Evaluate the percentage of inappropriate VT/VF detections
  2. characterize the true incidence of VT/VF detections
  3. therapy efficacy
  4. time to first inappropriate VT/VF detection
  5. incidence of untreated but monitored VT
  6. programming changes
  7. deaths and cardiovascular adverse event

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00279279

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Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Principal Investigator: Bruce Wilkoff, M.D The Cleveland Clinic

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00279279     History of Changes
Other Study ID Numbers: 223
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: October 26, 2006
Last Verified: October 2006

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Implantable cardioverter defibrillator (ICD)
Sudden Cardiac Death
Primary Prevention

Additional relevant MeSH terms:
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms