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Sponsored by: |
Boston Scientific Corporation |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00180336 |
The purpose of this study is to assess the safety and effectiveness of the CONTAK RENEWAL 4 AVT device.
Condition | Intervention | Phase |
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Heart Failure Tachycardia Atrial Fibrillation Atrial Flutter Ventricular Fibrillation |
Device: CRT-D |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | CONTAK RENEWAL 4 AVT Field Following |
Estimated Enrollment: | 170 |
Study Start Date: | July 2004 |
This is a prospective, two-arm, non-randomized, multi-center European field following, designed to demonstrate the safety and effectiveness of the CONTAK RENEWAL 4 AVT device in humans.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | Clinicals0004 |
Study First Received: | September 12, 2005 |
Last Updated: | June 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00180336 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Heart Failure Tachycardia Atrial Fibrillation Atrial Flutter Ventricular Fibrillation |
Heart Failure Heart Diseases Tachycardia Paroxysmal ventricular fibrillation |
Atrial Fibrillation Atrial Flutter Ventricular Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |