CURE-AF Trial Information

Trial Summary

This is a prospective, non-randomized multi-center clinical trial evaluating the outcome of patients with permanent AF requiring concomitant open heart surgery utilizing 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.

Study Endpoints

Primary Endpoints

• Freedom from atrial fibrillation and off antiarrhythmic drugs at 6 months
• Composite major adverse event rate at 1 month

Secondary Endpoints

• Freedom from atrial fibrillation at 6 months while on antiarrhythmic medication
• Composite major adverse event rate post-procedure to 6 months

Criteria

Patient Inclusion Criteria

Patients must meet all of the following criteria to be enrolled in the study:

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:
   1. Mitral valve repair or replacement
   2. Aortic valve repair or replacement
   3. Tricuspid valve repair or replacement
   4. Atrial septal defect (ASD) repair, patent foramen ovale (PFO) closure
   5. Coronary artery bypass procedure
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

Patient Exclusion Criteria

Patients who meet any of the following criteria may not be enrolled in the study:

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 atrial ablation, 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 during the study period
12. Current diagnosis of active systemic infection
13. Documented MI 6 weeks prior to study enrollment