Trial record 1 of 1 for:    00903370
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Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery

This study is currently recruiting participants.
Verified January 2013 by Mount Sinai School of Medicine
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Annetine Gelijns, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00903370
First received: May 14, 2009
Last updated: January 10, 2013
Last verified: January 2013
  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
Device: Mitral valve surgery with ligation/excision of left atrial appendage with ablation
Procedure: Mitral valve surgery with ligation/excision of left atrial appendage
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Freedom from atrial fibrillation [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: Measured at Month 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 260
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (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.
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:
  • Mitral Valve Repair
  • Mitral Valve Replacement
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.
Device: 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:
  • Mitral Valve Repair
  • Mitral Valve Replacement
  • Surgical Ablation

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903370

Contacts
Contact: Annetine Gelijns, PhD 212-659-9568 annetine.gelijns@mssm.edu
Contact: Paula Williams, MS 212-659-9562 paula.williams@mountsinai.org

  Hide Study Locations
Locations
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Abeel Mangi, MD    203-785-5252    abeel.mangi@yale.edu   
Contact: Lynn Wilson    203-737-8871    lynn.wilson@ynhh.org   
Principal Investigator: Abeel Mangi, MD         
United States, Delaware
Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19701
Contact: Ray Blackwell, MD    302-733-2658    rblackwell@christianacare.org   
Contact: Andrea Squire    302-733-2658    ASquire@ChristianaCare.org   
Principal Investigator: Ray Blackwell, MD         
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 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         
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: John Rousou, MD    413-794-5550    susan.parent@bhs.org   
Contact: Barbara Burkott    413-794-1305    barbara.burkott@baystatehealth.org   
Principal Investigator: John Rousou, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Steven Bolling, MD    734-936-4981    sbolling@med.umich.edu   
Contact: Cathie Bloem, MPH, RN    734-615-6170    bloem@umich.edu   
Principal Investigator: Steven Bolling, MD         
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         
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: David Adams, MD       david.adams@mountsinai.org   
Contact: Yael Mandel-Portnoy       yael.mandel-portnoy@mountsinai.org   
Principal Investigator: David Adams, 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 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 Recruiting
Columbus, Ohio, United States, 43210
Contact: Chittoor B Sai-Sudhakar, MBBS    614-293-9327    sai.sudhakar@osumc.edu   
Contact: Asia McDavid, MS    614-688-7904    asia.mcdavid@osumc.edu   
Principal Investigator: Chittoor B Sai-Sudhakar, MBBS         
United States, Pennsylvania
University of Pennsylvania 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: Geoffrey Gong    469-814-4735    gang.gong@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, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G2B7
Contact: John C Mullen, MD, MSc    780-407-6327    jmullen@ualberta.ca   
Contact: Emily Kuurstra    780-407-6327    emily.kuurstra@albertahealthsciences.ca   
Principal Investigator: John C Mullen, M.D., MSc         
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         
Sponsors and Collaborators
Annetine Gelijns
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. Mount Sinai School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Annetine Gelijns, Professor of Health Policy, Chair Department of Health Evidence & Policy, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00903370     History of Changes
Other Study ID Numbers: GCO 08-1078 0004, U01HL088942, U01HL088942-03, 656
Study First Received: May 14, 2009
Last Updated: January 10, 2013
Health Authority: United States: Food and Drug Administration
Canada: Canadian Institutes of Health Research

Keywords provided by Mount Sinai School of Medicine:
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

ClinicalTrials.gov processed this record on April 15, 2014