Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF

Korábbi kezelés

• Previous surgical or catheter ablation for AF
• Currently enrolled in an investigational study evaluating another device, biologic, or drug that would interfere with this trial

Más betegség

• Uncontrolled heart failure or New York Heart Association (NYHA) Class IV
• History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
• Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the PFA energy field

Életkor

• 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 the course of the clinical investigation

Egyéb

• Documented LA thrombus by imaging within 48 hours before procedure (CT, TEE, or intracardiac echocardiogram at the beginning of the procedure).
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
• Life expectancy less than 12 months

• Symptomatic paroxysmal and persistent AF with at least one AF episode electrocardiographically 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 consumer devices
• Age 18-80 years
• Willing and capable of providing written consent
• Able and willing to comply with all pre-, post- and follow-up testing and requirements.