Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Massachusetts General Hospital
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
Previous surgical or catheter ablation for AF
Documented LA thrombus by imaging within 48 hours before procedure (CT, TEE, or intracardiac 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 to anticoagulation (heparin, warfarin, or dabigatran)
Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other 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 the course 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
