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| Sponsor: | Boston Scientific Corporation |
|---|---|
| Information provided by: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT00180336 |
Purpose
The purpose of this study is to assess the safety and effectiveness of the CONTAK RENEWAL 4 AVT device.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure Tachycardia Atrial Fibrillation Atrial Flutter Ventricular Fibrillation |
Device: CRT-D |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00180336 History of Changes |
| Other Study ID Numbers: | Clinicals0004 |
| Study First Received: | September 12, 2005 |
| Last Updated: | June 22, 2007 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Heart Failure Tachycardia Atrial Fibrillation Atrial Flutter Ventricular Fibrillation |
|
Atrial Fibrillation Atrial Flutter Heart Failure Tachycardia Ventricular Fibrillation |
Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |