Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery

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.

Conditions

• Atrial Fibrillation
• Mitral Valve Insufficiency
• Mitral Valve Stenosis

Interventions

PROCEDURE

MVS

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.

DEVICE

Ablation

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Annetine Gelijns

  lead OTHER

Principal Investigators

• Timothy Gardner, MD · Christiana Care Health Services

• Patrick O'Gara, MD · Brigham and Women's Hospital

• Annetine C. Gelijns, Ph.D. · Icahn School of Medicine at Mount Sinai

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2015-09-30

Completion

2015-09-30

Countries

• United States
• Canada

Study Locations