Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation

Heart Failure, Congestive Clinical Trial

Official title:

VENTAK CHF/CONTAK CD Biventricular Pacing Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00387803
• Other study ID #: Clinicals0010
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 11, 2006
• Last updated: January 23, 2007
• Start date: February 1998
• Est. completion date: August 2001

Study information

• Verified date: January 2007
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 581
• Est. completion date: August 2001
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation

Intervention

Device:
• Cardiac Resynchronization Therapy with Defibrillation

Locations

Country	Name	City	State
United States	Multiple locations	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Higgins SL, Hummel JD, Niazi IK, Giudici MC, Worley SJ, Saxon LA, Boehmer JP, Higginbotham MB, De Marco T, Foster E, Yong PG. Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malig — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of all-cause mortality, heart failure hospitalization, and ventricular tachyarrhythmia
Secondary	Peak VO2
Secondary	NYHA Class
Secondary	Six minute walk distance
Secondary	Quality of life
Secondary	Echocardiographic measures