RecruitingNot ApplicableNCT06099730

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

Sponsor

Massachusetts General Hospital

Enrollment

442 participants

Start Date

Dec 14, 2023

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

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 Criteria9

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