Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery
Atrial Fibrillation, Mitral Valve Insufficiency, Mitral Valve Stenosis
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Mitral Valve Regurgitation, Mitral Valve Surgery, Mitral Valve Disease, Ablation, Catheter, Catheter Ablation, Radiofrequency
Eligibility Criteria
Inclusion Criteria:
- Able to sign Informed Consent and Release of Medical Information forms
- Age ≥ 18 years
Clinical indications for mitral valve surgery for the following:
- Organic mitral valve disease; or
- Functional non-ischemic mitral regurgitation; or
- Ischemic mitral regurgitation with evidence of concomitant structural mitral valve disease
Note: May include need for surgical management of functional tricuspid regurgitation or patent foramen ovale. May also include concomitant CABG, aortic arch or aortic valve procedure. Surgical intervention may be performed via sternotomy or minimally invasive procedure.
a) Persistent AF within 6 months prior to randomization, defined as non self-terminating AF lasting greater than 7 days but no more than one year, or lasting less than 7 days but necessitating pharmacologic or electrical cardioversion.
- Duration of AF must be documented by medical history and
- Presence of AF must be documented by a direct electrocardiographic assessment within 6 months prior to randomization.
b) Longstanding persistent AF is defined as continuous AF of greater than one year duration.
- Duration of AF must be documented by medical history and
- Presence of AF must be documented by a direct electrocardiographic assessment upon arrival in the OR.
- Able to use heart rhythm monitor
Exclusion Criteria:
- 1. AF without indication for mitral valve surgery 2. AF is paroxysmal 3. Evidence of left atrial thrombus by intra-operative TEE 4. Evidence of active infection 5. Mental impairment or other conditions that may not allow subject to understand the nature, significance, and scope of study 6. Surgical management of hypertrophic obstructive cardiomyopathy 7. Previous catheter ablation for AF 8. Life expectancy of less than one year 9. Absolute contraindications for anticoagulation therapy 10. Enrollment in concomitant drug or device trials 11. Uncontrolled hypo- or hyperthyroidism 12. FEV1 < 30% of predicted value and/or need for home oxygen therapy 13. Women who are pregnant as evidenced by positive pregnancy test 14. Women of childbearing age who do not agree to be on adequate birth control throughout the period of the trial.
Sites / Locations
- Yale New Haven Hospital
- Christiana Care Health Services
- Emory University
- University of Maryland
- NIH Heart Center at Suburban Hospital
- Brigham and Women's Hospital
- Baystate Medical Center
- University of Michigan
- Montefiore Einstein Heart Center
- Mount Sinai School of Medicine
- Columbia University Medical Center
- Duke University
- East Carolina Heart Institute
- Cleveland Clinic Foundation
- Ohio State University
- University of Pennsylvania
- Baylor Research Institute
- University of Virginia
- University of Alberta Hospital
- Montreal Heart Institute
- Quebec Heart Institute/Laval Hopital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
MVS
Ablation
All participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.
Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.