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Sponsored by: |
AtriCure, Inc. |
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Information provided by: | AtriCure, Inc. |
ClinicalTrials.gov Identifier: | NCT00571779 |
Feasibility study arm to evaluate the safety of adding the left atrial linear connecting lesions of the Cox-Maze lesion set to the current RESTORE SR II IDE study procedure of performing pulmonary vein isolation, selected left atrial autonomic ganglionated plexi (GP) ablation, and optional left atrial appendage (LAA) excision/exclusion on a beating heart for patients with permanent or persistent Atrial Fibrillation (AF).
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation |
Device: AtriCure Bipolar System |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Thoracoscopically-Assisted Epicardial Bilateral Pulmonary Vein Isolations Using the AtriCure Bipolar System and Exclusion of the Left Atrial Appendage for the Treatment of Atrial Fibrillation |
Estimated Enrollment: | 25 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient with documented symptomatic persistent or permanent AF and failure or intolerance of one or more Class I or Class III antiarrhythmic drugs.
Exclusion Criteria:
Contact: Madonna Katenkamp | 1-800-401-3506 | mkatenkamp@atricure.com |
Contact: Deborah Morley | 1-800-401-3506 | dmorley@atricure.com |
United States, Florida | |
Shands at University of Florida | |
Gainesville, Florida, United States, 32610 | |
United States, Maryland | |
Johns Hopkins | |
Baltimore, Maryland, United States, 21218 | |
United States, Ohio | |
Mt. Carmel East | |
Columbus, Ohio, United States, 43213 | |
United States, Texas | |
Baylor Heart Hospital | |
Plano, Texas, United States, 75093 | |
United States, Virginia | |
Medical College of Virginia | |
Richmond, Virginia, United States, 23298 |
Principal Investigator: | James Edgerton, MD | Baylor Heart Hospital |
Principal Investigator: | Kenneth Ellenbogen, MD | Medical College of Virginia |
Responsible Party: | AtriCure, Inc ( Deborah Morley ) |
Study ID Numbers: | CP2007-2 |
Study First Received: | December 10, 2007 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00571779 |
Health Authority: | United States: Food and Drug Administration |
Atrial Fibrillation AF AFIB racing heart |
pulmonary vein isolation pvi mini maze maze |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |