Status:
COMPLETED
Surgical Ablation Versus No Surgical Ablation for Patients With Atrial Fibrillation Undergoing Mitral Valve Surgery
Lead Sponsor:
Annetine Gelijns
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Atrial Fibrillation
Mitral Valve Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00903370
Start Date
January 1 2010
End Date
September 1 2015
Last Update
February 6 2017
Active Locations (21)
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1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
2
Christiana Care Health Services
Newark, Delaware, United States, 19701
3
Emory University
Atlanta, Georgia, United States, 30383
4
University of Maryland
Baltimore, Maryland, United States, 21201