Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
Pulsed Field Ablation (PFA): PFA using Irreversible Electroporation (IRE) Ablation System
Study summary
The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation in the treatment of subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation with the VARIPULSE™ catheter and the TRUPULSE™ generator.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Primary outcome measure(s)
Incidence of early onset primary adverse events (PAEs) — within seven (7) days of an ablation procedure
Freedom from documented atrial tachyarrhythmia episodes — effectiveness evaluation period (Day 91-Day 365)
Freedom from acute procedural failure — during ablation procedure
Trial sites (6)
Facility
City
Region
Status
St. Bernard's Heart and Vascular Center
Jonesboro
Arkansas
Recruiting
Massachusetts General Hospital
Boston
Massachusetts
Recruiting
Beth Israel Deaconess Medical Center
Boston
Massachusetts
Active Not Recruiting
Mount Sinai Hospital
New York
New York
Not Yet Recruiting
Montefiore Medical Center
New York
New York
Recruiting
Texas Cardiac Arrhythmia Institute/Research Foundation
Austin
Texas
Recruiting
More Massachusetts General Hospital trials in Israel
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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