Status:
WITHDRAWN
AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation
Lead Sponsor:
AtriCure, Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
ABLATE Persistent is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating persistent atrial fibrillation du...
Eligibility Criteria
Inclusion
- Subject is greater than or equal to 18 years of age
- Subject has history of persistent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines
- 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
- Subject's Left Ventricular Ejection Fraction ≥ 30%
- Subject is able and willing to provide written informed consent and comply with study requirements
- Subject has life expectancy of at least 1 year
Exclusion
- Patients with longstanding and continuous AF in which cardioversion has failed or has not been attempted
- Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure
- Wolff-Parkinson-White syndrome
- Prior cardiac surgery (Redo)
- Class IV NYHA heart failure symptoms
- Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit
- Documented MI within 6 weeks prior to study enrollment
- Need for emergent cardiac surgery (i.e. cardiogenic shock)
- Known carotid artery stenosis greater than 80%
- LA size greater than or equal to 8 cm
- Current diagnosis of active systemic infection
- Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
- Pregnancy or desire to get pregnant within 12-months of the study enrollment
- Preoperative need for an intra-aortic balloon pump or intravenous inotropes
- Renal failure requiring dialysis or hepatic failure
- Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
- Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00785902
Last Update
February 21 2011
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