Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation

Phase 2

Completed

• Conditions: Heart Failure, Congestive; Ventricular Fibrillation; Tachycardia, Ventricular

• Registration Number: NCT00387803
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 1998-02
• Study Completion: 2001-08
• Study First Submitted: 2006-10-11
• Study First Submitted QC: 2006-10-11
• Study First Posted: 2006-10-13
• Status Verified: 2007-01
• Last Update Submitted: 2007-01-23
• Last Update Posted: 2007-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 581

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite of all-cause mortality, heart failure hospitalization, and ventricular tachyarrhythmia

Secondary Outcome Measures

Name	Time	Method
Peak VO2
NYHA Class
Six minute walk distance
Quality of life
Echocardiographic measures

Trial Locations

Locations (1)

Multiple locations; 🇺🇸 Saint Paul, Minnesota, United States