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

Massachusetts General Hospital7 sites in 1 country360 target enrollmentDecember 14, 2023

ConditionsAtrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Massachusetts General Hospital
Enrollment: 360
Locations: 7
Primary Endpoint: Incidence of early onset primary adverse events (PAEs)
Status: Active, not recruiting
Last Updated: 12 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 14, 2023

End Date

November 2026

Last Updated

12 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Massachusetts General Hospital

Responsible Party

Principal Investigator

Moussa C Mansour

Massachusetts General Hospital

Eligibility Criteria

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