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

• ClinicalTrials.gov Identifier: NCT00903370
• Recruitment Status: Completed
• First Posted: May 18, 2009
• Results First Posted: November 22, 2016
• Last Update Posted: February 6, 2017
• Sponsor: Annetine Gelijns
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institute of Neurological Disorders and Stroke (NINDS); Canadian Institutes of Health Research (CIHR)
• Information provided by (Responsible Party): Annetine Gelijns, Icahn School of Medicine at Mount Sinai

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation; Mitral Valve Insufficiency; Mitral Valve Stenosis	Procedure: MVS; Device: Ablation	Phase 2

Detailed Description:

The purpose of this study is to determine whether the addition of surgical ablation to planned mitral valve surgery for patients with persistent or longstanding persistent AF (within 6 months prior to randomization) reduces the incidence of postoperative heart arrhythmia compared to mitral valve repair with medication therapy alone. This is a randomized, multi-center trial which will enroll 260 subjects who will be randomized in a 1:1 fashion to: (a) mitral valve surgery plus surgical ablation or (b) mitral valve surgery without ablation (control group). All patients will undergo ligation or excision of the left atrial appendage. Patients assigned to the ablation group will be further randomized (1:1) to one of two lesion sets: (1) pulmonary vein isolation only or (2) biatrial Maze lesions. The target population for this trial consists of adult patients with mitral valve disease requiring surgical intervention and persistent or longstanding persistent atrial fibrillation. All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity. The primary efficacy endpoint is freedom from AF, which will be measured by 3-day continuous monitoring at 6 months and 12 months post-ablation. The primary safety endpoint is a composite of death, stroke, serious cardiac events (heart failure, myocardial infarction), cardiac re-hospitalizations, transient ischemic attack, pulmonary embolism, peripheral embolism, excessive bleeding, deep sternal wound infection/mediastinitis, damage to specialized conduction system requiring permanent pacemaker, damage to peripheral structures, such as the esophagus, within 30 days post-procedure or hospital discharge (whichever is later).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Surgical Ablation Versus No Surgical Ablation for Patients With Persistent or Longstanding Persistent Atrial Fibrillation (AF) Undergoing Mitral Valve Surgery
• Study Start Date: January 2010
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: September 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: MVS; All participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.	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.; Other Names: Mitral Valve Repair; Mitral Valve Replacement
Experimental: Ablation; Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.	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.; Other Names: Mitral Valve Repair; Mitral Valve Replacement; 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.; Other Name: Surgical Ablation

Outcome Measures

Primary Outcome Measures :

1. Freedom From Atrial Fibrillation [ Time Frame: Measured at Month 12 ]

Secondary Outcome Measures :

1. Composite of Death, Stroke, Serious Adverse Events (Cardiac and Non-cardiac), and Cardiac Re-hospitalizations Less Than 30 Days Post-procedure or Hospital Discharge [ Time Frame: Less than 30 days post-procedure or hospital discharge ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Connecticut

Yale New Haven Hospital

New Haven, Connecticut, United States, 06510

United States, Delaware

Christiana Care Health Services

Newark, Delaware, United States, 19701

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30383

United States, Maryland

University of Maryland

Baltimore, Maryland, United States, 21201

NIH Heart Center at Suburban Hospital

Bethesda, Maryland, United States, 20892

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

United States, New York

Montefiore Einstein Heart Center

Bronx, New York, United States, 10467

Mount Sinai School of Medicine

New York, New York, United States, 10029

Columbia University Medical Center

New York, New York, United States, 10032

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27710

East Carolina Heart Institute

Greenville, North Carolina, United States, 27834

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Ohio State University

Columbus, Ohio, United States, 43210

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

United States, Texas

Baylor Research Institute

Plano, Texas, United States, 75093

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22908

Canada, Alberta

University of Alberta Hospital

Edmonton, Alberta, Canada, T6G2B7

Canada, Quebec

Montreal Heart Institute

Montreal, Quebec, Canada, H1T 1C8

Canada

Quebec Heart Institute/Laval Hopital

Quebec, Canada, H7M 3L9

Sponsors and Collaborators

Annetine Gelijns

National Heart, Lung, and Blood Institute (NHLBI)

National Institute of Neurological Disorders and Stroke (NINDS)

Canadian Institutes of Health Research (CIHR)

Investigators

• Study Chair: Timothy Gardner, MD; Christiana Care Health Services
• Study Chair: Patrick O'Gara, MD; Brigham and Women's Hospital
• Principal Investigator: Annetine C. Gelijns, Ph.D.; Icahn School of Medicine at Mount Sinai

More Information

Additional Information:

Click here for the Cardiothoracic Surgical Trials Network Web site 

Publications of Results:

Gillinov AM, Gelijns AC, Parides MK, DeRose JJ Jr, Moskowitz AJ, Voisine P, Ailawadi G, Bouchard D, Smith PK, Mack MJ, Acker MA, Mullen JC, Rose EA, Chang HL, Puskas JD, Couderc JP, Gardner TJ, Varghese R, Horvath KA, Bolling SF, Michler RE, Geller NL, Ascheim DD, Miller MA, Bagiella E, Moquete EG, Williams P, Taddei-Peters WC, O'Gara PT, Blackstone EH, Argenziano M; CTSN Investigators. Surgical ablation of atrial fibrillation during mitral-valve surgery. N Engl J Med. 2015 Apr 9;372(15):1399-409. doi: 10.1056/NEJMoa1500528. Epub 2015 Mar 16.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

DeRose JJ Jr, Mancini DM, Chang HL, Argenziano M, Dagenais F, Ailawadi G, Perrault LP, Parides MK, Taddei-Peters WC, Mack MJ, Glower DD, Yerokun BA, Atluri P, Mullen JC, Puskas JD, O'Sullivan K, Sledz NM, Tremblay H, Moquete E, Ferket BS, Moskowitz AJ, Iribarne A, Gelijns AC, O'Gara PT, Blackstone EH, Gillinov AM; CTSN Investigators. Pacemaker Implantation After Mitral Valve Surgery With Atrial Fibrillation Ablation. J Am Coll Cardiol. 2019 May 21;73(19):2427-2435. doi: 10.1016/j.jacc.2019.02.062.

• Responsible Party: Annetine Gelijns, Professor of Health Policy, Chair Department of Health Evidence & Policy, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT00903370
• Other Study ID Numbers: GCO 08-1078-0004; U01HL088942 ( U.S. NIH Grant/Contract ); U01HL088942-03 ( U.S. NIH Grant/Contract ); 656 ( Other Identifier: Cardiothoracic Surgical Trials Network )
• First Posted: May 18, 2009
• Results First Posted: November 22, 2016
• Last Update Posted: February 6, 2017
• Last Verified: December 2016

Keywords provided by Annetine Gelijns, Icahn School of Medicine at Mount Sinai:

Mitral Valve Regurgitation; Mitral Valve Surgery; Mitral Valve Disease; Ablation, Catheter; Catheter Ablation, Radiofrequency

Additional relevant MeSH terms:

Atrial Fibrillation; Mitral Valve Insufficiency; Mitral Valve Stenosis; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Valve Diseases