Status:
COMPLETED
Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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) dev...
Detailed 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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
816 Patients enrolled
Trial Details
Trial ID
NCT00187200
Start Date
January 1 2005
End Date
April 1 2010
Last Update
February 5 2019
Active Locations (1)
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1
Ohio State University
Columbus, Ohio, United States, 43210