AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: AtriCure Bipolar System
Intervention description: Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atrial fibrillation; af; ablation; arrhythmia; racing heart; afib; surgical ablation

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is greater than or equal to 18 years of age

          2. Subject has history of permanent 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

               -  Atrial Septal Defect Repair

               -  Patent Foramen Ovale closure

          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, ASD repair,
             or PFO closure

          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