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A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation
Sponsor: Biosense Webster, Inc.
Summary
The purpose of this study is to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat heart rhythm disease). This includes isolation of pulmonary vein and superior vena cava (heart veins; pulmonary vein isolation \[PVI\] and superior vena cava isolation \[SVCI\]), with or without another technique called posterior wall isolation (PWI). Also, to assess how safe it is for participants who are having a catheter ablation procedure and at the same time receiving another procedure called left atrial appendage occlusion (LAAO; to reduce stroke risk). Additionally, to assess how well VARIPULSE catheter system works over a long period of time for treatment of PsAF in participants undergoing catheter ablation for PVI, SVCI and SVCI+PWI.
Official title: Assessment of the Safety and Effectiveness of the VARIPULSE™ Catheter System in the Treatment of Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein (With or Without Posterior Wall Isolation) and Superior Vena Cava Isolation: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1070
Start Date
2026-08-26
Completion Date
2031-08-24
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
VARIPULSE Catheter System
Pulsed field ablation by VARIPULSE Catheter System (VARIPULSE bi-directional catheter and TRUPULSE generator) will be used.
LAAO Device
LAAO procedures will be performed using commercially available LAAO devices in accordance with the device's instruction for use (IFU).
Locations (13)
Grandview Medical Center
Birmingham, Alabama, United States
Pima Heart and Vascular
Tucson, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Pacific Heart Institute Cedars Sinai Medical Center
Santa Monica, California, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
JFK Medical Center
Atlantis, Florida, United States
Saint Elizabeth Medical Center
Edgewood, Kentucky, United States
Munson Medical Center
Traverse City, Michigan, United States
Albert Einstein College Of Medicine - Montefiore Medical Center
The Bronx, New York, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Mercy Hospital
Janesville, Wisconsin, United States