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Sponsored by: |
AtriCure, Inc. |
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Information provided by: | AtriCure, Inc. |
ClinicalTrials.gov Identifier: | NCT00560885 |
ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating permanent atrial fibrillation during concomitant on-pump cardiac surgery.
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation |
Device: AtriCure Bipolar System |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | AtriCure Synergy Bipolar RF Energy Lesions for Permanent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery |
Estimated Enrollment: | 75 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (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 is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:
Exclusion Criteria:
Contact: Madonna Katenkamp | 1-800-401-3506 | mkatenkamp@atricure.com |
Contact: Deborah Morley, PhD | 1-800-401-3506 | dmorley@atricure.com |
United States, California | |
Mercy Heart Institute | Recruiting |
Sacramento, California, United States, 95819 | |
Contact: Sarah Bordash, RN, BSN 916-453-4493 sarah.bordash@chw.edu | |
Principal Investigator: Alan Morris, MD | |
Sutter Health | Recruiting |
Sacramento, California, United States, 95819 | |
Contact: Linda Frankenstein, RN, BSN, CCRC 916-733-7102 frankel@sutterhealth.org | |
Principal Investigator: James Longoria, MD | |
United States, Indiana | |
Heart Center of Indiana | Recruiting |
Indianapolis, Indiana, United States, 46290 | |
Contact: Mary Anne Gfell 317-583-7812 magfell@corvascmds.com | |
Principal Investigator: David Heimansohn, MD | |
United States, Michigan | |
Spectrum Health | Recruiting |
Grand Rapids, Michigan, United States, 49503 | |
Contact: Julie Bishop, RN, BSN 616-391-2724 julie.bishop@spectrum-health.org | |
Principal Investigator: Robert Hooker, MD | |
Munson Medical Center | Recruiting |
Traverse City, Michigan, United States, 49684 | |
Contact: Jane Stauffer, BSN, CCRC 231-935-6826 jstauffer@mhc.net | |
Principal Investigator: Mack Stirling, MD | |
United States, Ohio | |
Case Western | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Valerie Cwiklinski, RN 216-844-2328 valerie.cwiklinski@UHhospitals.org | |
Principal Investigator: Alan Markowitz, MD | |
United States, Texas | |
Baylor Heart Hospital | Recruiting |
Dallas, Texas, United States, 75230 | |
Contact: Shannon Hoffman, RN shannon.hoffman@baylorhealth.edu | |
Principal Investigator: Michael Mack, MD | |
United States, Virginia | |
Inova Fairfax | Recruiting |
Falls Church, Virginia, United States, 22042 | |
Contact: Christine Pierre 410-465-2455 | |
Principal Investigator: Niv Ad, MD | |
Carilion Roanoke Memorial Hospital | Recruiting |
Roanoke, Virginia, United States, 24014 | |
Contact: Barbara Agnew, RN 540-892-6123 bagnew@carilion.com | |
Principal Investigator: Joseph Baker, MD | |
Sentara Norfolk General Hospital | Recruiting |
Norfolk, Virginia, United States, 23507 | |
Contact: Laura Pine, RN, BSN, CCRC 757-668-2732 ljpine@sentara.com | |
Principal Investigator: Hormoz Azar, MD |
Principal Investigator: | Niv Ad, MD | Inova Heart Hospital |
Responsible Party: | AtriCure, Inc ( Deborah Morley ) |
Study ID Numbers: | CP2007-1 |
Study First Received: | November 19, 2007 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00560885 |
Health Authority: | United States: Food and Drug Administration |
atrial fibrillation af ablation arrhythmia |
racing heart afib surgical ablation |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |