AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation

AtriCure

Status and phase: Withdrawn; Phase 3

Conditions: Atrial Fibrillation

Treatments: Device: AtriCure Bipolar System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00785902

CP2008-1

Details and patient eligibility

About

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 during concomitant on-pump cardiac surgery.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is greater than or equal to 18 years of age

2. Subject has history of persistent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines

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. Patients with longstanding and continuous AF in which cardioversion has failed or has not been attempted
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 8 cm
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