Phase
Condition
Cardiac Disease
Chest Pain
Atrial Fibrillation
Treatment
Cardioblate and Cryoflex hand held devices
Surgical Ablation
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
New York Heart Association (NYHA) Class = IV
Left Ventricular Ejection Fraction ≤ 30%
Need for emergent cardiac surgery (ie, cardiogenic shock) or redo open heart surgery
Previous AF ablation, atrioventricular (AV) -nodal ablation, or surgical Mazeprocedure
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 StatesCompleted
Adventist Health St. Helena
Saint Helena, California 94574
United StatesSite Not Available
Adventist Health St. Helena
St. Helena, California 94574
United StatesSite Not Available
Stanford Hospitals and Clinic
Palo Alto 5380748, California 5332921 94304
United StatesSite Not Available
Adventist Health St. Helena
St. Helena 5390267, California 5332921 94574
United StatesSite Not Available
Hartford Healthcare
Hartford, Connecticut 06102
United StatesCompleted
Hartford Healthcare
Hartford 4835797, Connecticut 4831725 06102
United StatesSite Not Available
St Vincent Heart Center of Indiana
Indianapolis, Indiana 46290
United StatesActive - Recruiting
St Vincent Heart Center of Indiana
Indianapolis 4259418, Indiana 4921868 46290
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
Corewell Health
Grand Rapids, Michigan 49503
United StatesActive - Recruiting
Spectrum Health Hospitals
Grand Rapids, Michigan 49503
United StatesActive - Recruiting
Corewell Health
Grand Rapids 4994358, Michigan 5001836 49503
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
St Louis, Missouri 63110
United StatesActive - Recruiting
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
ProMedica Toledo
Toledo, Ohio 43606
United StatesCompleted
ProMedica Toledo
Toledo 5174035, Ohio 5165418 43606
United StatesSite Not Available
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United StatesActive - Recruiting
Lankenau Medical Center
Wynnewood, Pennsylvania 19096
United StatesCompleted
Allegheny General Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15212
United StatesSite Not Available
Lankenau Medical Center
Wynnewood 5220230, Pennsylvania 6254927 19096
United StatesSite Not Available
Intermountain Medical Center
Murray, Utah 84107
United StatesActive - Recruiting
Intermountain Medical Center
Murray 5778755, Utah 5549030 84107
United StatesSite Not Available
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United StatesCompleted
Sentara Norfolk General Hospital
Norfolk 4776222, Virginia 6254928 23507
United StatesSite Not Available
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
Swedish Medical Center
Seattle 5809844, Washington 5815135 98122
United StatesSite Not Available
Virginia Mason Heart Institute
Seattle 5809844, Washington 5815135 98101
United StatesActive - Recruiting
St. Joseph Medical Center
Tacoma 5812944, Washington 5815135 98405
United StatesSite Not Available

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