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PREPARE - Primary Prevention Parameters Evaluation

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00279279
First received: January 17, 2006
Last updated: October 25, 2006
Last verified: October 2006
History of Changes
  Purpose

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 Intervention
Tachycardia, Ventricular
Implantable Cardioverter Defibrillator (ICD)
Fibrillation, Ventricular
Syncope
 Device: Implanted Device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: PREPARE - Primary Prevention Parameters Evaluation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

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

Estimated Enrollment: 700
Study Start Date: October 2003
Estimated Study Completion Date: May 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279279

  Show 32 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Medtronic
Investigators
Principal Investigator: Bruce Wilkoff, M.D The Cleveland Clinic
  More Information

No publications provided by Medtronic Cardiac Rhythm Disease Management

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00279279     History of Changes
Other Study ID Numbers: 223
Study First Received: January 17, 2006
Last Updated: October 25, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Implantable cardioverter defibrillator (ICD)
Sudden Cardiac Death
Primary Prevention

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

ClinicalTrials.gov processed this record on May 16, 2013