Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients
The purpose of the study is to evaluate the benefit of interventricular (V-V) delay optimization in reducing the non-responder rate in patients with cardiac resynchronization defibrillator (CRT-D) devices. The primary endpoint of this study is CRT responder rate.
For patients enrolled with new CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:
- < 10% improvement in 6-minute hall walk, and
- no class improvement or worsening in New York Heart Association (NYHA) scale.
For those receiving CRT-D devices as replacements of older CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:
- > 1 heart failure (HF) related hospitalization, and
- no class improvement or worsening in NYHA scale.
Device: CRT-D system
Device: Optimization of interventricular intervals
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||RESPONSE HF - Response of Cardiac Resynchronization Therapy Optimization With V-V Timing in Heart Failure Patients|
- Quality of life
- Cardiac reverse remodeling
- NYHA class progression
- Left ventricular ejection fraction (LVEF)
- HF related hospitalizations
|Study Start Date:||January 2005|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
- This is a prospective, randomized (simultaneous BiV pacing vs. sequential BiV pacing) study.
- Any patient that receives an FDA approved SJM CRT-D with V-V timing is eligible for enrollment.
- At 3 months post enrollment (or at implant for CRT-D replacements), patients screened as non-responders are randomized to either simultaneous or sequential BiV pacing. Patients requiring a replacement CRT-D device that are identified as non-responders to CRT are enrolled at the screening/randomization visit.
Patients are followed for a period of 6 months post randomization:
- Enrollment (1 week pre CRT-D implant to < 2 weeks post CRT-D implant)
- Screening/Randomization Visit (3 months post enrollment)
- Follow-up Visit (6 months post randomization)
- Total # of centers - 80 centers
- Sample size - 800 patients screened for CRT non-responders (200 randomized patients)