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Sponsored by: |
St. Jude Medical |
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Information provided by: | St. Jude Medical |
ClinicalTrials.gov Identifier: | NCT00187200 |
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:
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:
Condition | Intervention | Phase |
---|---|---|
Heart Failure |
Device: CRT-D system Device: Optimization of interventricular intervals |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | RESPONSE HF - Response of Cardiac Resynchronization Therapy Optimization With V-V Timing in Heart Failure Patients |
Estimated Enrollment: | 200 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Study Methods
Patients are followed for a period of 6 months post randomization:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients requiring a CRT-D replacement must comply with BOTH of the following:
Exclusion Criteria:
Contact: Ashish Oza, MS | (818) 493-3648 | aoza@sjm.com |
Contact: Ronald LaVallee | 818-493-3014 |
United States, Ohio | |
Ohio State University | Recruiting |
Columbus, Ohio, United States | |
Contact: Raul Weiss, MD | |
Principal Investigator: Raul Weiss, MD |
Principal Investigator: | Raul Weiss, MD | Ohio State University |
Responsible Party: | Ohio State University ( Dr. Raul Weiss ) |
Study ID Numbers: | CRD299 |
Study First Received: | September 10, 2005 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00187200 History of Changes |
Health Authority: | United States: Institutional Review Board |
Heart Failure Heart Diseases |
Heart Failure Heart Diseases Cardiovascular Diseases |