Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
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
Conditions
Interventions
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