Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery
Completed · Phase 2
Conditions studied: Atrial Fibrillation, Mitral Valve Insufficiency, Mitral Valve Stenosis
In brief
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.
Key facts
- Study ID
- NCT00903370
- Run by
- Annetine Gelijns
- People needed
- 260
- Starts
- 2010-01-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2017-02-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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…
- 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.
Where it is running
- Yale New Haven Hospital — New Haven, Connecticut, United States
- Christiana Care Health Services — Newark, Delaware, United States
- Emory University — Atlanta, Georgia, United States
- University of Maryland — Baltimore, Maryland, United States
- NIH Heart Center at Suburban Hospital — Bethesda, Maryland, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Baystate Medical Center — Springfield, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Mount Sinai School of Medicine — New York, New York, United States
- Columbia University Medical Center — New York, New York, United States
- Montefiore Einstein Heart Center — The Bronx, New York, United States
- Duke University — Durham, North Carolina, United States
- East Carolina Heart Institute — Greenville, North Carolina, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Ohio State University — Columbus, Ohio, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Baylor Research Institute — Plano, Texas, United States
- University of Virginia — Charlottesville, Virginia, United States
- University of Alberta Hospital — Edmonton, Alberta, Canada
- Montreal Heart Institute — Montreal, Quebec, Canada
- Quebec Heart Institute/Laval Hopital — Québec, Quebec, Canada
Full record on ClinicalTrials.gov
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