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Sponsored by: |
AtriCure, Inc. |
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Information provided by: | AtriCure, Inc. |
ClinicalTrials.gov Identifier: | NCT00779857 |
Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.
Condition | Intervention | Phase |
---|---|---|
Left Atrial Appendage Exclusion |
Device: AtriCure LAA Exclusion System |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Exclusion of the Left Atrial Appendage With the AtriClip LAA Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery |
Estimated Enrollment: | 60 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject has any one of the following risk factors and is thought to benefit from LAA occlusion:
Exclusion Criteria:
Contact: Madonna Katenkamp | 1-800-401-3506 | mkatenkamp@atricure.com |
United States, Georgia | |
Macon Medical Center | Recruiting |
Macon, Georgia, United States, 31201 | |
Contact: Craig Odum 478-743-9762 c.odum@maconcvi.org | |
Principal Investigator: Richard Harvey, MD | |
United States, Indiana | |
St. Francis Heart Hospital | Recruiting |
Indianapolis, Indiana, United States, 45237 | |
Contact: Katherine Lawson, BSN 317-851-2582 katherine.lawson@ssfhs.org | |
Principal Investigator: Marc Gerdisch, MD | |
United States, Michigan | |
Spectrum Health | Recruiting |
Grand Rapids, Michigan, United States, 49506 | |
Contact: Jennifer Cannestra, BSN 616-391-2904 jennifer.cannestra@spectrum-health.org | |
Contact: Julie Bishop, BSN (616) 391-2724 julie.bishop@spectrum-health.org | |
Principal Investigator: Robert Hooker, MD | |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Tracey Guthrie, RN 314-747-4404 guthriet@wustl.edu | |
Principal Investigator: Jennifer Lawton, MD | |
United States, Texas | |
Baylor Heart Hospital | Recruiting |
Plano, Texas, United States, 75093 | |
Contact: Shannon Hoffman, BSN 469-814-3466 shannon.hoffman@baylorhealth.edu | |
Contact: Lisa Plummer, BSN 4698143466 lisapl@baylorhealth.edu | |
Principal Investigator: Michael Mack, MD | |
United States, Virginia | |
University of Virginia | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: Sandra Burks, PhD 434-243-0315 sgb2c@virginia.edu | |
Principal Investigator: Gorav Ailawadi, MD |
Principal Investigator: | Michael Mack, MD | Baylor Heart Hospital |
Responsible Party: | AtriCure, Inc ( James Lucky ) |
Study ID Numbers: | CP2008-2 |
Study First Received: | October 23, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00779857 |
Health Authority: | United States: Food and Drug Administration |
left atrial appendage laa atrial fibrillation afib |
af stroke tia |
Cerebral Infarction Stroke Atrial Fibrillation |