PREPARE - Primary Prevention Parameters Evaluation

NCT ID: NCT00279279

Last Updated: 2006-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tachycardia, Ventricular Implantable Cardioverter Defibrillator (ICD) Fibrillation, Ventricular Syncope

Keywords

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Implantable cardioverter defibrillator (ICD) Sudden Cardiac Death Primary Prevention

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Implanted Device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Principal Investigators

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Bruce Wilkoff, M.D

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Birmingham, Alabama, United States

Site Status

Mesa, Arizona, United States

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Phoenix, Arizona, United States

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San Diego, California, United States

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San Pablo, California, United States

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Newark, Delaware, United States

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Fort Lauderdale, Florida, United States

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Jacksonville, Florida, United States

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Merrit Island, Florida, United States

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Columbus, Georgia, United States

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Maywood, Illinois, United States

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Rockford, Illinois, United States

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Topeka, Kansas, United States

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Portland, Maine, United States

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Silver Spring, Maryland, United States

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Takoma Park, Maryland, United States

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Boston, Massachusetts, United States

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Royal Oak, Michigan, United States

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Minneapolis, Minnesota, United States

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Paterson, New Jersey, United States

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Buffalo, New York, United States

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New York, New York, United States

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Columbus, Ohio, United States

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Elyria, Ohio, United States

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Bethlehem, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Columbia, South Carolina, United States

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Nashville, Tennessee, United States

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Amarillo, Texas, United States

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Kirkland, Washington, United States

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Morgantown, West Virginia, United States

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San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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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.

Reference Type DERIVED
PMID: 21605131 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18687248 (View on PubMed)

Other Identifiers

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223

Identifier Type: -

Identifier Source: org_study_id