Phase
Condition
Chest Pain
Cardiac Disease
Dysrhythmia
Treatment
Farapulse PFA, Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation
Farapulse PFA, Pulmonary Vein Isolation alone
Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation
Clinical Study ID
Ages 21-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for theduration of the study.
Age 21-90 years.
Symptomatic PAF whether failed AAD or not.
At least one symptomatic episode of PAF lasting <7 days, documented onelectrocardiogram (ECG), Holter, ZioPatch, ILR, or smartwatch recording in the yearprior to enrollment.
Patients undergoing first time ablation for AF.
Subject has any commercially available implantable loop recorder (ILR) or agrees tohave one implanted prior or during the ablation procedure.
Exclusion
Exclusion Criteria:
Persistent atrial fibrillation (PeAF) (> 7 days in duration).
Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or otherreversible non-cardiac cause.
Previous surgical or catheter ablation of AF.
Previous valve surgery, ventriculotomy, atriotomy, or presence of a mitralmechanical prosthetic or bioprosthetic valve.
Left atrium anteroposterior (LA AP) diameter >55 mm or indexed left atrium (LA)volume >48 ml/m2.
Contraindications to oral or systemic anticoagulation.
Previous thromboembolic event (including ischemic strokes and TIA) within the last 3months.
Previous myocardial infarction or percutaneous coronary intervention within the past 2 months.
Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days).
Pregnancy.
History of PV stenosis.
History of severe pulmonary hypertension.
History of diaphragmatic paresis or hemi-paresis.
History of heart transplantation.
History of blood clotting or bleeding abnormalities.
Life expectancy of less than 12 months.
Presence of intracardiac thrombus.
Complex congenital heart disease, including tetralogy of Fallot, ventricular septaldefects, Ebstein's anomaly, systemic right ventricle, and transposition of the greatarteries.
Intracardiac or vascular abnormalities that preclude adequate catheter introductionor manipulation within the LA.
Pacing dependent patients.
Active malignancy or history of treated malignancy within 12 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma).
Active systemic infection.
Participation in any other AF-related randomized clinical trial.
Study Design
Study Description
Connect with a study center
Grandview Medical Center
Birmingham, Alabama 35243
United StatesSite Not Available
Grandview Medical Center
Birmingham 4049979, Alabama 4829764 35243
United StatesSite Not Available
MedStar Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
MedStar Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 20010
United StatesSite Not Available
St. Vincent's Health System, Inc. d/b/a Ascension St. Vincent's
Jacksonville, Florida 32204
United StatesSite Not Available
HCA Florida Mercy Hospital
Miami, Florida 33133
United StatesSite Not Available
St. Vincent's Health System, Inc. d/b/a Ascension St. Vincent's
Jacksonville 4160021, Florida 4155751 32204
United StatesSite Not Available
HCA Florida Mercy Hospital
Miami 4164138, Florida 4155751 33133
United StatesSite Not Available
St. Luke's Boise Medical Center
Boise, Idaho 83712
United StatesSite Not Available
St. Luke's Boise Medical Center
Boise 5586437, Idaho 5596512 83712
United StatesSite Not Available
Maine Medical Center
Portland, Maine 04102
United StatesSite Not Available
Maine Medical Center
Portland 4975802, Maine 4971068 04102
United StatesSite Not Available
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
United StatesSite Not Available
Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
United StatesSite Not Available
Lahey Hospital and Medical Center
Burlington 4931737, Massachusetts 6254926 01805
United StatesSite Not Available
Corewell Health William Beaumont Hospital
Royal Oak, Michigan 48073
United StatesSite Not Available
Corewell Health William Beaumont Hospital
Royal Oak 5007804, Michigan 5001836 48073
United StatesSite Not Available
The Valley Hospital
Paramus, New Jersey 07652
United StatesSite Not Available
The Valley Hospital
Paramus 5102387, New Jersey 5101760 07652
United StatesSite Not Available
North Shore University Hospital, Northwell Health
Manhasset, New York 11030
United StatesSite Not Available
North Shore University Hospital, Northwell Health
Manhasset 5125766, New York 5128638 11030
United StatesSite Not Available
Doylestown Hospital
Doylestown, Pennsylvania 18901
United StatesSite Not Available
Doylestown Hospital
Doylestown 5187247, Pennsylvania 6254927 18901
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Trident Medical Center
Charleston, South Carolina 29406
United StatesActive - Recruiting
Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
United StatesSite Not Available
Trident Medical Center
Charleston 4574324, South Carolina 4597040 29406
United StatesSite Not Available
Orion Medical
Houston, Texas 77034
United StatesSite Not Available
Methodist Hospital-San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United StatesActive - Recruiting
Orion Medical
Houston 4699066, Texas 4736286 77034
United StatesSite Not Available
Methodist Hospital-San Antonio
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
University of Texas Health Science Center at San Antonio
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
University of Washington Medical Center
Seattle, Washington 98195
United StatesSite Not Available
University of Washington Medical Center
Seattle 5809844, Washington 5815135 98195
United StatesSite Not Available

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