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| Sponsor: | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Collaborators: |
National Institute of Neurological Disorders and Stroke (NINDS) Canadian Institutes of Health Research (CIHR) |
| Information provided by (Responsible Party): | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00903370 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation Mitral Valve Insufficiency Mitral Valve Stenosis |
Procedure: Mitral valve surgery with ligation/excision of left atrial appendage with ablation Procedure: Mitral valve surgery with ligation/excision of left atrial appendage |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 |
| Estimated Enrollment: | 260 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: MVS alone
Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.
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Procedure: Mitral valve surgery with ligation/excision of left atrial appendage
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:
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Experimental: MVS + 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.
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Procedure: Mitral valve surgery with ligation/excision of left atrial appendage with 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 Names:
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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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Clinical indications for mitral valve surgery for the following:
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.
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.
Exclusion Criteria:
Contacts and Locations| Contact: Annetine Gelijns, PhD | 212-659-9568 | annetine.gelijns@mssm.edu |
| Contact: Ellen Moquete, RN, BSN | 212-659-9651 | ellen.moquete@mountsinai.org |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30383 | |
| Contact: John Puskas, MD 404-686-2513 john_puskas@emoryhealthcare.org | |
| Contact: Alexis Neill, RN 404-686-3575 alexis.neill@emoryhealthcare.org | |
| Principal Investigator: John Puskas, MD | |
| United States, Maryland | |
| University of Maryland | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: James Gammie, MD 410-328-5842 jgammie@smail.umaryland.edu | |
| Contact: Cindi Young 410-328-8149 cyoung@smail.umaryland.edu | |
| Principal Investigator: James S Gammie, MD | |
| NIH Heart Center at Suburban Hospital | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: Keith Horvath, MD 301-451-7098 khorvath@nih.gov | |
| Contact: Mandy Murphy, RN 301-896-3775 mmurphy@suburbanhospital.org | |
| Principal Investigator: Keith Horvath, MD | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Not yet recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Frederick Y Chen, MD 617-732-7775 fchen@partners.org | |
| Contact: Debra Conboy, RN 617-732-7019 daconboy@partners.org | |
| Principal Investigator: Frederick Y Chen, MD, PhD | |
| United States, New York | |
| Montefiore Einstein Heart Center | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Robert E. Michler, MD 718-920-2100 rmichler@montefiore.org | |
| Contact: Roger Swayze, RN 718-920-2221 rswayze@montefiore.org | |
| Principal Investigator: Robert E. Michler, MD | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Michael Argenziano, MD 212-305-5888 ma66@columbia.edu | |
| Contact: Lyn Goldsmith, MA, RN, CCRC 212-342-0261 lg2240@columbia.edu | |
| Principal Investigator: Michael Argenziano, MD | |
| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Peter Smith, MD 919-684-2890 smith058@mc.duke.edu | |
| Contact: Stacey Welsh, RN stacey.welsh@duke.edu | |
| Principal Investigator: Peter Smith, MD | |
| East Carolina Heart Institute | Not yet recruiting |
| Greenville, North Carolina, United States, 27834 | |
| Contact: T. Bruce Ferguson, MD 252-744-5232 Fergusont@ecu.edu | |
| Contact: Malissa Harris, RN 252-744-5287 Harrismal@ecu.edu | |
| Principal Investigator: T. Bruce Ferguson, MD | |
| United States, Ohio | |
| Cleveland Clinic Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Eugene Blackstone, MD 216-444-6712 blackse@ccf.org | |
| Contact: Kathy Sankovic, RN, CCRC 216-445-6916 sankovk@ccf.org | |
| Principal Investigator: Eugene Blackstone, MD | |
| Sub-Investigator: Mark Gillinov, MD | |
| Ohio State University | Not yet recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Chittoor B Sai-Sudhakar, MBBS 614-293-9327 sai.sudhakar@osumc.edu | |
| Contact: Danielle Jones, RN 614-366-8506 danielle.jones@osumc.edu | |
| Principal Investigator: Chittoor B Sai-Sudhakar, MBBS | |
| United States, Pennsylvania | |
| University of Pennsylvania | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Michael Acker, MD 215-349-8305 michael.acker@uphs.upenn.edu | |
| Contact: Mary Lou Mayer, RN 215-662-7981 marylou.mayer@uphs.upenn.edu | |
| Principal Investigator: Michael Acker, MD | |
| United States, Texas | |
| Baylor Research Institute | Recruiting |
| Plano, Texas, United States, 75093 | |
| Contact: Michael Mack, MD 469-814-4105 michaelma@baylorhealth.edu | |
| Contact: Jennifer Withers, RN, CCRC 469-814-5691 jennw@baylorhealth.edu | |
| Principal Investigator: Michael Mack, MD | |
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Irving L. Kron, MD 434-924-2158 ilk@virginia.edu | |
| Contact: Sandra Burks, RN 434-243-0315 sgb2c@virginia.edu | |
| Principal Investigator: Irving L. Kron, MD | |
| Canada, Quebec | |
| Montreal Heart Institute | Recruiting |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Contact: Louis Perrault, MD, PhD 514-376-3330 louis.perrault@icm-mhi.org | |
| Contact: Sophie Robichaud 514-376-3330 ext 3305 Sophie.Robichaud@icm-mhi.org | |
| Principal Investigator: Louis Perrault, MD, PhD | |
| Canada | |
| Quebec Heart Institute/Laval Hopital | Recruiting |
| Quebec, Canada, H7M 3L9 | |
| Contact: Pierre Voisine, MD 418 656-4717 pierre.voisine@chg.ulaval.ca | |
| Contact: Gladys Dussault, RN 418-656-8711 ext 2765 gladys.dussault@criucpq.ulaval.ca | |
| Principal Investigator: Pierre Voisine, MD | |
| Study Chair: | Timothy Gardner, MD | Christiana Care Health System |
| Study Chair: | Patrick O'Gara, MD | Brigham and Women's Hospital |
More Information
| Responsible Party: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00903370 History of Changes |
| Other Study ID Numbers: | 656, U01 HL088942-03 |
| Study First Received: | May 14, 2009 |
| Last Updated: | September 26, 2011 |
| Health Authority: | United States: Food and Drug Administration; Canada: Canadian Institutes of Health Research |
|
Mitral Valve Regurgitation Mitral Valve Surgery Mitral Valve Disease Ablation, Catheter Catheter Ablation, Radiofrequency |
|
Atrial Fibrillation Mitral Valve Insufficiency Mitral Valve Stenosis Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes Heart Valve Diseases |
