Phase
Condition
Arrhythmia
Chest Pain
Dysrhythmia
Treatment
Epicardial And Endocardial RF Ablation For The Treatment Of Symptomatic Long-standing Persistent AF
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years and < 80 years at time of enrollment consent;
Left atrium ≤ 6.0 cm assessed with Transthoracic Echocardiography [TTE] withparasternal 4 chamber view or equivalent imaging modality;
Refractory or intolerant to at least one AAD (class I and/or III);
Subject has symptomatic (e.g. palpitations, shortness of breath, fatigue)longstanding persistent atrial fibrillation as defined by the 2017 HRS/EHRA/ECASGuidelines (> 12 months of continuous AF);
Life expectancy > 12 months; and
Provides written informed consent.
Exclusion
Exclusion Criteria:
Patients requiring concomitant surgery such as valvular repair or replacement,coronary artery bypass graft (CABG) surgery and atrial septal defect closure;
Left ventricular ejection fraction < 35%;
Pregnant or planning to become pregnant during study;
Co-morbid medical conditions that limit one-year life expectancy;
Previous cardiac surgery;
History of pericarditis;
Previous cerebrovascular accident (CVA), excluding fully resolved TIA;
Patients who have active infection or sepsis
Patients with esophageal ulcers strictures and varices;
Patients with renal dysfunction who are not on dialysis (defined as GFR ≤ 40);
Patients who are contraindicated for anticoagulants such as heparin and coumadin;
Patients who are being treated for ventricular arrhythmias;
Patients who have had more than 2 prior left atrial catheter ablations for AF. NOTE:Note: Prior ablations should be limited to failed Pulmonary Vein Isolation (PVI) andno other left atrial lesions;
Current participation in another clinical investigation of a medical device or adrug, or recent participation in such a study within 30 days prior to studyenrollment;
Not competent to legally represent him or herself (e.g., requires a guardian orcaretaker as a legal representative);
Patient has presence of thrombus in the left atrium determined by intraoperativeTEE;
Patient exhibits pulmonary vein stenosis in one or more of the pulmonary veins >50 %stenosis;
Planned Left Atrial Appendage Management (LAAM) with an endocardial implantabledevice during the course of the study;
Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation results
Presence of Barretts esophagitis
Study Design
Study Description
Connect with a study center
St Thomas
London, Se1 7EH
United KingdomSite Not Available
St Thomas
London 2643743, Se1 7EH
United KingdomSite Not Available
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
United StatesSite Not Available
Eisenhower Medical Center
Rancho Mirage, California 92270
United StatesSite Not Available
Sutter Bay Hospitals
San Francisco, California 94107
United StatesSite Not Available
Sutter Bay Hospitals
San Francisco 5391959, California 5332921 94107
United StatesSite Not Available
Bridgeport Hospital System
Bridgeport, Connecticut 06610
United StatesSite Not Available
Hartford Hospital
Hartford, Connecticut 06102
United StatesSite Not Available
Hartford Hospital
Hartford 4835797, Connecticut 4831725 06102
United StatesSite Not Available
Baycare Health Systems
Clearwater, Florida 33759
United StatesSite Not Available
Orlando Health
Orlando, Florida 32806
United StatesSite Not Available
Baycare Health Systems
Clearwater 4151316, Florida 4155751 33759
United StatesSite Not Available
Orlando Health
Orlando 4167147, Florida 4155751 32806
United StatesSite Not Available
Emory Saint Joseph Hopsital
Atlanta, Georgia 30322
United StatesSite Not Available
Wellstar Health System
Marietta, Georgia 30062
United StatesSite Not Available
Emory Saint Joseph Hopsital
Atlanta 4180439, Georgia 4197000 30322
United StatesSite Not Available
Wellstar Health System
Marietta 4207783, Georgia 4197000 30062
United StatesSite Not Available
Ascension St. Vincent
Indianapolis, Indiana 46260
United StatesSite Not Available
Norton Heart & Vascular Institute
Louisville, Kentucky 40205
United StatesSite Not Available
Norton Heart & Vascular Institute
Louisville 4299276, Kentucky 6254925 40205
United StatesSite Not Available
MedStar Union Memorial Hospital
Baltimore, Maryland 21218
United StatesSite Not Available
MedStar Union Memorial Hospital
Baltimore 4347778, Maryland 4361885 21218
United StatesSite Not Available
Southcoast Hospitals Group
New Bedford, Massachusetts 02740
United StatesSite Not Available
Southcoast Hospitals Group
New Bedford 4945121, Massachusetts 6254926 02740
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Nebraska Methodist Hospital
Omaha, Nebraska 68114
United StatesSite Not Available
AtlantiCare Medical Center
Atlantic City, New Jersey 08401
United StatesSite Not Available
AtlantiCare Medical Center
Atlantic City 4500546, New Jersey 5101760 08401
United StatesSite Not Available
Northwell - North Shore University Hospital
Manhasset, New York 11042
United StatesSite Not Available
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Avera Heart Hospital of SD
Sioux Falls, South Dakota 57108
United StatesSite Not Available
Avera Heart Hospital of SD
Sioux Falls 5231851, South Dakota 5769223 57108
United StatesSite Not Available
HCA Dallas North Texas Heart Center
Dallas, Texas 75243
United StatesSite Not Available
Methodist Stone Oak
San Antonio, Texas 78258
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84112
United StatesSite Not Available
University of Utah
Salt Lake City 5780993, Utah 5549030 84112
United StatesSite Not Available
Bon Secours
Midlothian, Virginia 23114
United StatesSite Not Available
Virginia Mason Medical Center
Seattle, Washington 98101
United StatesSite Not Available

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