Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation

Boston Scientific

Status and phase: Completed; Phase 3; Phase 2

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

Treatments: Device: Cardiac Resynchronization Therapy with Defibrillation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00387803

Clinicals0010

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind