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Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00387803
First Posted: October 13, 2006
Last Update Posted: January 25, 2007
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.
Information provided by:
Boston Scientific Corporation
  Purpose
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 Intervention Phase
Heart Failure, Congestive Ventricular Fibrillation Tachycardia, Ventricular Device: Cardiac Resynchronization Therapy with Defibrillation Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: VENTAK CHF/CONTAK CD Biventricular Pacing Study

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

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

Secondary Outcome Measures:
  • Peak VO2
  • NYHA Class
  • Six minute walk distance
  • Quality of life
  • Echocardiographic measures

Estimated Enrollment: 581
Study Start Date: February 1998
Estimated Study Completion Date: August 2001
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00387803


Locations
United States, Minnesota
Multiple locations
Saint Paul, Minnesota, United States, 55112
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00387803     History of Changes
Other Study ID Numbers: Clinicals0010
First Submitted: October 11, 2006
First Posted: October 13, 2006
Last Update Posted: January 25, 2007
Last Verified: January 2007

Additional relevant MeSH terms:
Heart Failure
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes