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Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation

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: NCT00387803
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : January 25, 2007
Information provided by:
Boston Scientific Corporation

Brief Summary:
The purpose of this study was to determine if cardiac resynchronization therapy when combined with defibrillation is safe and effective in the treatment of symptomatic heart failure.

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Ventricular Fibrillation Tachycardia, Ventricular Device: Cardiac Resynchronization Therapy with Defibrillation Phase 2 Phase 3

Detailed Description:
Patients enrolled received a device with cardiac resynchronization therapy (CRT) and defibrillation. Patients were randomized to CRT on or off for up to six months and evaluated for mortality, hospitalization, and functional outcomes including exercise capacity, quality of life, symptomatic status, and echocardiographic analysis.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 581 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: VENTAK CHF/CONTAK CD Biventricular Pacing Study
Study Start Date : February 1998
Study Completion Date : August 2001

Primary Outcome Measures :
  1. Composite of all-cause mortality, heart failure hospitalization, and ventricular tachyarrhythmia

Secondary Outcome Measures :
  1. Peak VO2
  2. NYHA Class
  3. Six minute walk distance
  4. Quality of life
  5. Echocardiographic measures

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Symptomatic heart failure
  • Left ventricular ejection fraction <= 35%
  • QRS width >= 120 ms
  • Indicated for an implantable cardioverter defibrillator

Exclusion Criteria:

  • Indicated for a pacemaker
  • Atrial tachyarrhythmias

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): NCT00387803

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United States, Minnesota
Multiple locations
Saint Paul, Minnesota, United States, 55112
Sponsors and Collaborators
Boston Scientific Corporation
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Principal Investigator: Steven Higgins, MD Scripps Memorial Hospital
Principal Investigator: Leslie A Saxon, MD University of California San Francisco Medical Center
Principal Investigator: John Boehmer, MD Milton S. Hershey Medical Center
Principal Investigator: Teresa De Marco, MD University of California San Francisco Medical Center

Publications of Results:
Layout table for additonal information Identifier: NCT00387803     History of Changes
Other Study ID Numbers: Clinicals0010
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: January 25, 2007
Last Verified: January 2007
Additional relevant MeSH terms:
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Heart Failure
Ventricular Fibrillation
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes