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| Sponsor: | Boston Scientific Corporation |
|---|---|
| Information provided by (Responsible Party): | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT00158977 |
Purpose
The RENEWAL 3 AVT device is designed to treat patients suffering from HF, with a history of or at risk of developing atrial and ventricular arrhythmias
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure Atrial Fibrillation |
Device: CONTAK RENEWAL 3 AVT |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CONTAK RENEWAL 3 AVT Study |
| Enrollment: | 73 |
| Study Start Date: | November 2003 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
A clinical evaluation to:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who meet the following criteria should be given consideration for inclusion in the clinical investigation:
NOTE: Guidant recommends anticoagulation therapy per physician discretion.
Exclusion Criteria:
Patients who will be excluded from the investigation are those who meet any one of the following criteria:
Note: Women of childbearing potential must have a negative pregnancy test within 7 days of enrollment
Contacts and Locations
More Information
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT00158977 History of Changes |
| Other Study ID Numbers: | Clinicals0008 |
| Study First Received: | September 8, 2005 |
| Last Updated: | September 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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heart failure atrial fibrillation cardiac resynchronization therapy defibrillator |
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Atrial Fibrillation Heart Failure Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes |