Heart Failure, Congestive, Tachycardia, Ventricular, Ventricular Fibrillation
Conditions
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.
Interventions
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of all-cause mortality, heart failure hospitalization, and ventricular tachyarrhythmia | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak VO2 | — |
| NYHA Class | — |
| Six minute walk distance | — |
| Quality of life | — |
| Echocardiographic measures | — |
Countries
United States
Outcome results
None listed