NCT00903370|CompletedPhase 2ResultsDMC
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Sponsor study identifier
Secondary identifiers
interventional
260
2 countries
21
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2015
Actual (reported)Study Completion
September 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 14, 2009
Actual (reported)May 18, 2009
Actual (reported)January 2010
Date type not reportedThis date has not been verified as actual or estimated.
September 2015
Actual (reported)September 2015
Actual (reported)November 22, 2016
Actual (reported)Freedom From Atrial Fibrillation
Measured at Month 12
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
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.
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.
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
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.
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.
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
260 participants (actual enrollment reported by the registry).
First Submitted
May 14, 2009
First Posted
May 18, 2009
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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
Primary Completion
September 2015
Actual (reported)Study Completion
September 2015
Actual (reported)Last Updated
February 6, 2017
Results First Posted
November 22, 2016
Record last verified: 2016-12
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Source: ClinicalTrials.gov.
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