Phase
Condition
Atrial Fibrillation
Dysrhythmia
Chest Pain
Treatment
Pulsed Field Ablation (PFA)
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Symptomatic paroxysmal and persistent AF with at least one AF episodeelectrocardiographically documented within 24 months prior to enrollment.Electrocardiographic documentation may include, but is not limited to ECG,Transtelephonic monitoring (TTM), Zio patch monitor, telemetry strip, or consumerdevices
Age 18-80 years
Willing and capable of providing written consent
Able and willing to comply with all pre-, post- and follow-up testing andrequirements.
Exclusion
Exclusion Criteria:
Previous surgical or catheter ablation for AF
Documented LA thrombus by imaging within 48 hours before procedure (CT, TEE, orintracardiac echocardiogram at the beginning of the procedure).
Uncontrolled heart failure or New York Heart Association (NYHA) Class IV
History of blood clotting, bleeding abnormalities or contraindication toanticoagulation (heparin, warfarin, or dabigatran)
Significant congenital anomaly or medical problem that in the opinion of theinvestigator would preclude enrollment in this study
Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) orother implanted metal cardiac device that may interfere with the PFA energy field
Women who are pregnant (as evidenced by pregnancy test if pre- menopausal),lactating, or who are of child-bearing age and plan on becoming pregnant during thecourse of the clinical investigation
Life expectancy less than 12 months
Currently enrolled in an investigational study evaluating another device, biologic,or drug that would interfere with this trial
Study Design
Connect with a study center
St. Bernard's Heart and Vascular Center
Jonesboro, Arkansas 72401
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Montefiore Medical Center
New York, New York 10467
United StatesSite Not Available
Mount Sinai Hospital
New York, New York 10029
United StatesSite Not Available
Texas Cardiac Arrhythmia Institute/Research Foundation
Austin, Texas 78705
United StatesActive - Recruiting

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