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| Sponsor: | 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 |
| Study Type: | Interventional |
| 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 |
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
More Information
| ClinicalTrials.gov Identifier: | NCT00571779 History of Changes |
| Other Study ID Numbers: | CP2007-2 |
| Study First Received: | December 10, 2007 |
| Last Updated: | February 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |