Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery
4 other identifiers
interventional
260
2 countries
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 atrial-fibrillation
Started Jan 2010
Longer than P75 for phase_2 atrial-fibrillation
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2009
CompletedFirst Posted
Study publicly available on registry
May 18, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
November 22, 2016
CompletedFebruary 6, 2017
December 1, 2016
5.7 years
May 14, 2009
September 30, 2016
December 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Freedom From Atrial Fibrillation
Measured at Month 12
Secondary Outcomes (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
Less than 30 days post-procedure or hospital discharge
Study Arms (2)
MVS
ACTIVE COMPARATORAll participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.
Ablation
EXPERIMENTALParticipants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Christiana Care Health Services
Newark, Delaware, 19701, United States
Emory University
Atlanta, Georgia, 30383, United States
University of Maryland
Baltimore, Maryland, 21201, United States
NIH Heart Center at Suburban Hospital
Bethesda, Maryland, 20892, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Einstein Heart Center
The Bronx, New York, 10467, United States
Duke University
Durham, North Carolina, 27710, United States
East Carolina Heart Institute
Greenville, North Carolina, 27834, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Baylor Research Institute
Plano, Texas, 75093, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
University of Alberta Hospital
Edmonton, Alberta, T6G2B7, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Quebec Heart Institute/Laval Hopital
Québec, Quebec, H7M 3L9, Canada
Related Publications (2)
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.
PMID: 25853744RESULTDeRose 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.
PMID: 31097163DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Annetine C. Gelijns, PhD
- Organization
- Icahn School of Medicine at Mount Sinai
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Health Policy, Chair Department of Health Evidence & Policy
Study Record Dates
First Submitted
May 14, 2009
First Posted
May 18, 2009
Study Start
January 1, 2010
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
February 6, 2017
Results First Posted
November 22, 2016
Record last verified: 2016-12