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Sponsored by: |
Boston Scientific Corporation |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00158951 |
The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the CONTAK® RENEWAL™ 2/4/4HE cardiac resynchronization therapy defibrillator (CRT-D) family and EASYTRAK® 2 lead in delivering LV-CRT or BiV-CRT with an LV Offset for patients with heart failure and an indication for an ICD.
Condition | Intervention | Phase |
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Congestive Heart Failure |
Device: CONTAK RENEWAL 2/4/4HE CRT-D Device: EASYTRAK 2 Lead |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Device Evaluation of CONTAK(R) RENEWAL 2/4/4HE and EASYTRAK(R) 2: Assessment of Safety and Effectiveness in Heart Failure (DECREASE-HF) |
Estimated Enrollment: | 360 |
Study Start Date: | March 2003 |
Estimated Study Completion Date: | October 2004 |
This clinical investigation is a prospective, multi-center, randomized, double-blind study design enrolling 360 patients at 57 centers to demonstrate the safety and effectiveness of the therapy, the CONTAK RENEWAL 2/4/4HE devices and the EASYTRAK 2 lead.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | Clinicals0005 |
Study First Received: | September 8, 2005 |
Last Updated: | June 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00158951 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Left Ventricular Lead Cardiac Resynchronization Therapy Congestive Heart Failure |
Heart Failure Heart Diseases |
Heart Failure Heart Diseases Cardiovascular Diseases |