Phase
Condition
Chest Pain
Arrhythmia
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 KingdomActive - Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California 92663
United StatesSite Not Available
Sutter Bay Hospitals
San Francisco, California 94107
United StatesActive - Recruiting
Hartford Hospital
Hartford, Connecticut 06102
United StatesActive - Recruiting
Baycare Health Systems
Clearwater, Florida 33759
United StatesActive - Recruiting
Emory Saint Joseph Hopsital
Atlanta, Georgia 30322
United StatesActive - Recruiting
Ascension St. Vincent
Indianapolis, Indiana 46260
United StatesActive - Recruiting
MedStar Union Memorial Hospital
Baltimore, Maryland 21218
United StatesActive - Recruiting
Southcoast Hospitals Group
New Bedford, Massachusetts 02740
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84112
United StatesActive - Recruiting
Bon Secours
Midlothian, Virginia 23114
United StatesActive - Recruiting
Virginia Mason Medical Center
Seattle, Washington 98101
United StatesActive - Recruiting
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