Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Cardioblate System Surgical Ablation System; Surgical RF Ablation
Intervention description: This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.; This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Permanent Atrial Fibrillation Surgical RF Ablation; Permanent Atrial Fibrillation

Summary:

      This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the
      outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery
      plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The
      trial population includes patients requiring valve replacements or repairs, atrial septal
      defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass graft
      (CABG) procedures. The study objectives are to demonstrate that the Medtronic Cardioblate
      Surgical Ablation System can safely and effectively treat permanent AF patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have a documented history of permanent AF (cardioversion failure) as
             defined by the ACC/AHA/ESC Guidelines.

          2. Concomitant indication (other than AF) for open-heart surgery for one or more of the
             following:

               -  Mitral valve repair or replacement

               -  Aortic valve repair or replacement

               -  Tricuspid valve repair or replacement

               -  Atrial septal defect (ASD) repair

               -  Patent foramen ovale (PFO) closure

               -  Coronary artery bypass procedures

          3. Greater than or equal to 18 years of age

          4. Able and willing to comply with study requirements by signing a consent form

          5. Must be able to take the anticoagulant warfarin (Coumadin)

        Exclusion Criteria:

          1. Wolff-Parkinson-White syndrome

          2. NYHA Class = IV

          3. Left ventricular ejection fraction ≤ 30%

          4. Need for emergent cardiac surgery (i.e. cardiogenic shock)

          5. Previous ablation for atrial fibrillation, AV-nodal ablation, or surgical Maze
             procedure

          6. Contraindication for anticoagulation therapy

          7. Left atrial diameter > 7.0 cm

          8. Preoperative need for an intra-aortic balloon pump or intravenous inotropes

          9. Renal failure requiring dialysis or hepatic failure

         10. Life expectancy of less than one year

         11. Pregnancy or desire to be pregnant within 12 months of the study treatment.

         12. Current diagnosis of active systemic infection

         13. Documented MI 6 weeks prior to study enrollment