At a glance
ClinicalIndex Comparison Record- ✓Standard indication for CRT-D (cardiac resynchronization therapy defibrillator)
- ✓Ability to complete 6-minute walk test with only fatigue or dyspnea as limiting factor
- ✓Geographically stable and willing to comply with follow-up schedule
- ✓Heart failure medications stable for 1 month prior to randomization and throughout study
- ✕Life expectancy less than 12 months
- ✕Cardiac surgery within 6 months of enrollment
- ✕Epicardial ventricular lead system in place
- ✕Age less than 18 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
RESPONSE HF - Response of Cardiac Resynchronization Therapy Optimization With Interventricular (VV) Timing in Heart Failure Patients
In Brief
A Phase 4 clinical trial evaluating Simultaneous VV Pacing and Sequential VV Pacing for Heart Failure. Completed, enrolled 816 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Right ventricular and left ventricular pacing delivered simultaneously.
Right ventricular and left ventricular pacing delivered sequentially.