Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study

Covidien

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Procedure: Surgical RF Ablation; Device: Cardioblate System Surgical Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00431834

CURE-AF/Permanent

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)