Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery
Condition: Atrial Fibrillation; Mitral Valve Insufficiency; Mitral Valve Stenosis
MeSH terms: Atrial Fibrillation; Mitral Valve Insufficiency; Mitral Valve Stenosis
Intervention: MVS; Ablation
Intervention description: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed.; For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins. For participants treated with biatrial maze lesion set, the left atrial lesions will include, the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture is noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture is noted, additional ablations on the atrial cuff will be performed until isolation is confirmed. This will be repeated on the left pulmonary veins.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mitral Valve Regurgitation; Mitral Valve Surgery; Mitral Valve Disease; Ablation, Catheter; Catheter Ablation, Radiofrequency

Summary:

      The purpose of the research is to determine whether treating atrial fibrillation with
      surgical ablation during scheduled mitral valve surgery is better than mitral valve surgery
      by itself without the surgical ablation. Surgical ablation of atrial fibrillation is a
      technique used by surgeons to deaden atrial heart tissue and block electrical signals that
      may be causing your heart to beat irregularly. There are no new procedures being tested in
      this study; both mitral valve surgery and surgical ablation are used regularly in patients
      who have mitral valve problems and atrial fibrillation, although no surgical ablation devices
      have been approved by the Food and Drug Administration for the treatment of atrial
      fibrillation. What is not known with certainty, is whether patients with atrial fibrillation
      who are having planned mitral valve surgery would do better if they also had surgical
      ablation rather than medication alone to treat their atrial fibrillation.
    

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:

               1. Organic mitral valve disease; or

               2. Functional non-ischemic mitral regurgitation; or

               3. 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.