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ABLATE Continued Access Trial - NCT01174745-49503(Clinical Trial 721295)



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City:  Grand Rapids
State:  
MI
Zip Code: 49503
Conditions: Atrial Fibrillation
Purpose: ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating longstanding persistent atrial fibrillation.
Study summary:
Criteria: Inclusion Criteria: 1. Subject is greater than or equal to 18 years of age 2. Subject has history of longstanding persistent AF 3. Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following: - Mitral valve repair or replacement - Aortic valve repair or replacement - Tricuspid valve repair or replacement - Coronary Artery Bypass procedures 4. Subject's Left Ventricular Ejection Fraction ≥ 30% 5. Subject is able and willing to provide written informed consent and comply with study requirements 6. Subject has life expectancy of at least 1 year Exclusion Criteria: 1. Stand alone AF without indication(s) for concomitant CABG, valve surgery 2. Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure 3. Wolff-Parkinson-White syndrome 4. Prior cardiac surgery (Redo) 5. Class IV NYHA heart failure symptoms 6. Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit 7. Documented MI within 6 weeks prior to study enrollment 8. Need for emergent cardiac surgery (i.e. cardiogenic shock) 9. Known carotid artery stenosis greater than 80% 10. LA size greater than or equal to 8cm 11. Current diagnosis of active systemic infection 12. Severe peripheral arterial occlusive disease defined as claudication with minimal exertion 13. Pregnancy or desire to get pregnant within 12-months of the study enrollment 14. Preoperative need for an intra-aortic balloon pump or intravenous inotropes 15. Renal failure requiring dialysis or hepatic failure 16. Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia 17. Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders
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Data Source: ClinicalTrials.gov
Date Processed: November 12, 2010
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