Heart Failure Clinical Trial
Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients
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.
Full Description
Study Methods
This is a prospective, randomized (simultaneous biventricular (BiV) pacing vs. sequential BiV pacing) study.
Any patient that receives an FDA approved St. Jude Medical (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
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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There is 1 Location for this study
Columbus Ohio, 43210, United States
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