Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation

Boston Scientific Corporation581 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

581

Conditions

Heart Failure, Congestive Ventricular Fibrillation Tachycardia, Ventricular

Interventions

Cardiac Resynchronization Therapy with DefibrillationDEVICE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Multiple locations

Saint Paul, Minnesota, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

Peak VO2

NYHA Class

Six minute walk distance

Quality of life

Echocardiographic measures

Data from ClinicalTrials.gov

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