Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients
Completed · Phase 4
Conditions studied: Heart Failure
In brief
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.
Key facts
- Study ID
- NCT00187200
- Run by
- Abbott Medical Devices
- People needed
- 816
- Starts
- 2005-01-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2019-02-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient has a standard indication for a CRT-D.
- Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath.
- Patient is geographically stable and willing to comply with the required follow-up schedule.
- Prior to 1 month of randomization, patient's HF medications are maintained stable and remain stable throughout the study.
- Patients requiring a CRT-D replacement must comply with BOTH of the following:
- > 1 HF related hospitalization
- No class improvement or worsening in NYHA scale
You may not qualify if…
- Patient's life expectancy is less than 12 months.
- Patient has had cardiac surgery within 6 months of enrollment.
- Patient has an epicardial ventricular lead system.
- Patient is less than 18 years old.
- Patient is pregnant.
Where it is running
- Ohio State University — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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