Phase
Condition
Chest Pain
Atrial Fibrillation
Arrhythmia
Treatment
Surgical Ablation
Cardioblate and Cryoflex hand held devices
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
History of non-paroxysmal AF (persistent or longstanding persistent)
Concomitant indication for non-emergent open-heart surgery, eg,
Coronary artery bypass grafting
Valve repair or replacement
- Able to take the anticoagulant warfarin or novel oral anticoagulants (NOAC)
Exclusion
Exclusion Criteria:
Wolff-Parkinson-White syndrome
NYHA Class = IV
Left Ventricular Ejection Fraction ≤ 30%
Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery
Previous AF ablation, AV-nodal ablation, or surgical Maze procedure
Contraindication for anticoagulation therapy
Left atrial diameter > 6.0 cm
Preoperative need for an intra-aortic balloon pump or intravenous inotropes
Renal failure requiring dialysis or hepatic failure
Life expectancy of less than 1 year
Predicted risk of operative mortality >10% as assessed by STS Risk Calculator
Pregnancy or desire to be pregnant within 12 months of the study treatment
Current diagnosis of active systemic infection
Active endocarditis
Documented MI 30 days prior to study enrollment
Current or planned participation in an investigational or observational drug ordevice trial related to the treatment of atrial arrhythmias
Study Design
Study Description
Connect with a study center
Stanford Hospitals and Clinic
Palo Alto, California 94304
United StatesActive - Recruiting
Adventist Health St. Helena
Saint Helena, California 94574
United StatesActive - Recruiting
Hartford Healthcare
Hartford, Connecticut 06102
United StatesActive - Recruiting
St Vincent Heart Center of Indiana
Indianapolis, Indiana 46290
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Spectrum Health Hospitals
Grand Rapids, Michigan 49503
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
ProMedica Toledo
Toledo, Ohio 43606
United StatesActive - Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United StatesActive - Recruiting
Lankenau Medical Center
Wynnewood, Pennsylvania 19096
United StatesActive - Recruiting
Intermountain Medical Center
Murray, Utah 84107
United StatesActive - Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United StatesCompleted
Swedish Medical Center
Seattle, Washington 98122
United StatesActive - Recruiting
Virginia Mason Heart Institute
Seattle, Washington 98101
United StatesActive - Recruiting
St. Joseph Medical Center
Tacoma, Washington 98405
United StatesSite Not Available
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