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| Sponsored by: |
AtriCure, Inc. |
| Information provided by: | AtriCure, Inc. |
| ClinicalTrials.gov Identifier: | NCT00571779 |
Purpose
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 |
| Genetics Home Reference related topics: | Brugada syndrome familial atrial fibrillation short QT syndrome |
| 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 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Eligibility
| 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:
Contacts and Locations| 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 | Not yet recruiting | ||||
| Gainesville, Florida, United States, 32610 | |||||
| Contact: Nancy Staples 352-273-5496 staplnl@surgery.ufl.edu | |||||
| Principal Investigator: Tom Beaver, MD | |||||
| Principal Investigator: Bill Miles, MD | |||||
| United States, Maryland | |||||
| Johns Hopkins | Not yet recruiting | ||||
| Baltimore, Maryland, United States, 21218 | |||||
| Principal Investigator: David Yuh, MD | |||||
| Principal Investigator: Hugh Calkins, MD | |||||
| United States, Ohio | |||||
| Mt. Carmel East | Not yet recruiting | ||||
| Columbus, Ohio, United States, 43213 | |||||
| Contact: Mary Ann McCleery 614-546-4297 mccleery@mchs.com | |||||
| Principal Investigator: Tom Salamon, MD | |||||
| Principal Investigator: Seth Rials, MD | |||||
| United States, Texas | |||||
| Baylor Heart Hospital | Not yet recruiting | ||||
| Plano, Texas, United States, 75093 | |||||
| Contact: Shannon Hoffman, RN shannon.hoffman@baylorhealth.edu | |||||
| Principal Investigator: James Edgerton, MD | |||||
| Principal Investigator: Michael Mack, MD | |||||
| United States, Virginia | |||||
| Medical College of Virginia | Not yet recruiting | ||||
| Richmond, Virginia, United States, 23298 | |||||
| Contact: Geoffrey Newton gnewton@mvch-vcu.edu | |||||
| Principal Investigator: Kenneth Ellenbogen, MD | |||||
| AtriCure, Inc. |
| Principal Investigator: | James Edgerton, MD | Baylor Heart Hospital |
| Principal Investigator: | Kenneth Ellenbogen, MD | Medical College of Virginia |
More Information
| Responsible Party: | AtriCure, Inc ( Deborah Morley ) |
| Study ID Numbers: | CP2007-2 |
| First Received: | December 10, 2007 |
| Last Updated: | June 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00571779 |
| Health Authority: | United States: Food and Drug Administration |
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