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Sponsored by: |
Boston Scientific Corporation |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00158977 |
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 |
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Heart Failure Atrial Fibrillation |
Device: CONTAK RENEWAL 3 AVT |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | CONTAK RENEWAL 3 AVT Study |
Enrollment: | 73 |
Study Start Date: | November 2003 |
Estimated Study Completion Date: | February 2008 |
Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
A clinical evaluation to:
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
Responsible Party: | Boston Scientific ( Steve McQuillan, Director of Clinical Affairs ) |
Study ID Numbers: | Clinicals0008 |
Study First Received: | September 8, 2005 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00158977 History of Changes |
Health Authority: | United States: Food and Drug Administration |
heart failure atrial fibrillation cardiac resynchronization therapy defibrillator |
Heart Failure Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Heart Failure Pathologic Processes Heart Diseases |
Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |