PREPARE - Primary Prevention Parameters Evaluation

October 25, 2006 updated by: Medtronic Cardiac Rhythm and Heart Failure
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Mesa, Arizona, United States
      • Phoenix, Arizona, United States
    • California
      • San Diego, California, United States
      • San Pablo, California, United States
    • Delaware
      • Newark, Delaware, United States
    • Florida
      • Ft. Lauderdale, Florida, United States
      • Jacksonville, Florida, United States
      • Merrit Island, Florida, United States
    • Georgia
      • Columbus, Georgia, United States
    • Illinois
      • Maywood, Illinois, United States
      • Rockford, Illinois, United States
    • Kansas
      • Topeka, Kansas, United States
    • Maine
      • Portland, Maine, United States
    • Maryland
      • Silver Spring, Maryland, United States
      • Takoma Park, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Royal Oak, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • New Jersey
      • Paterson, New Jersey, United States
    • New York
      • Buffalo, New York, United States
      • New York, New York, United States
    • Ohio
      • Columbus, Ohio, United States
      • Elyria, Ohio, United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Amarillo, Texas, United States
    • Washington
      • Kirkland, Washington, United States
    • West Virginia
      • Morgantown, West Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

Medtronic

Investigators

  • Principal Investigator: Bruce Wilkoff, M.D, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion

December 7, 2022

Study Completion

May 1, 2006

Study Registration Dates

First Submitted

January 17, 2006

First Submitted That Met QC Criteria

January 17, 2006

First Posted (Estimate)

January 19, 2006

Study Record Updates

Last Update Posted (Estimate)

October 26, 2006

Last Update Submitted That Met QC Criteria

October 25, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 223

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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