Expired Study
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Columbus, Ohio 43210


Purpose:

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 summary:

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


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.


NCT ID:

NCT00187200


Primary Contact:

Principal Investigator
Raul Weiss, MD
Ohio State University


Backup Contact:

N/A


Location Contact:

Columbus, Ohio 43210
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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