Phase
Condition
Atrial Fibrillation
Chest Pain
Arrhythmia
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is greater than or equal to 18 years of age
Subject has history of permanent atrial fibrillation as defined by the ACC/AHA/ESCGuidelines
Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for oneor more of the following:
Mitral valve repair or replacement
Aortic valve repair or replacement
Tricuspid valve repair or replacement
Coronary Artery Bypass procedures
Atrial Septal Defect Repair
Patent Foramen Ovale closure
Subject's Left Ventricular Ejection Fraction ≥ 30%
Subject is able and willing to provide written informed consent and comply with studyrequirements
Subject has life expectancy of at least 1 year
Exclusion
Exclusion Criteria:
Stand alone AF without indication(s) for concomitant CABG, valve surgery, ASD repair,or PFO closure
Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgicalMaze procedure
Wolff-Parkinson-White syndrome
Prior cardiac surgery (Redo)
Class IV NYHA heart failure symptoms
Prior history of cerebrovascular accidents within 6 months or at any time if there isresidual neurological deficit
Documented MI within 6 weeks prior to study enrollment
Need for emergent cardiac surgery (i.e. cardiogenic shock)
Known carotid artery stenosis greater than 80%
LA size greater than or equal to 8cm
Current diagnosis of active systemic infection
Severe peripheral arterial occlusive disease defined as claudication with minimalexertion
Pregnancy or desire to get pregnant within 12-months of the study enrollment
Preoperative need for an intra-aortic balloon pump or intravenous inotropes
Renal failure requiring dialysis or hepatic failure
Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
Therapy resulting in compromised tissue integrity including: thoracic radiation,chemotherapy, long term treatment with oral or injected steroids, or known connectivetissue disorders
Study Design
Connect with a study center
Mercy Heart Institute
Sacramento, California 95819
United StatesSite Not Available
Sutter Health
Sacramento, California 95819
United StatesSite Not Available
Heart Center of Indiana
Indianapolis, Indiana 46290
United StatesSite Not Available
Spectrum Health
Grand Rapids, Michigan 49503
United StatesSite Not Available
Munson Medical Center
Traverse City, Michigan 49684
United StatesSite Not Available
Baylor Heart Hospital
Dallas, Texas 75230
United StatesSite Not Available
Inova Fairfax
Falls Church, Virginia 22042
United StatesSite Not Available
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United StatesSite Not Available
Carilion Roanoke Memorial Hospital
Roanoke, Virginia 24014
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.