Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00387803
First received: October 11, 2006
Last updated: January 23, 2007
Last verified: January 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 11, 2006
Last Updated: January 23, 2007
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014