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ACTIVE NOT RECRUITING
NCT06099730
NA

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2023-12-14

Completion Date

2026-11

Last Updated

2025-05-06

Healthy Volunteers

No

Interventions

DEVICE

Pulsed Field Ablation (PFA)

PFA using Irreversible Electroporation (IRE) Ablation System

Locations (7)

St. Bernard's Heart and Vascular Center

Jonesboro, Arkansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Mount Sinai Hospital

New York, New York, United States

Montefiore Medical Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Texas Cardiac Arrhythmia Institute/Research Foundation

Austin, Texas, United States