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RECRUITING
NCT07527299
NA

A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation

Sponsor: Biosense Webster, Inc.

View on ClinicalTrials.gov

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; PVI and 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.

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

920

Start Date

2026-08-05

Completion Date

2031-08-04

Last Updated

2026-06-22

Healthy Volunteers

No

Interventions

DEVICE

VARIPULSE Catheter System

Pulsed field ablation by VARIPULSE Catheter System (VARIPULSE bi-directional catheter and TRUPULSE generator) will be used.

DEVICE

LAAO Device

LAAO procedures will be performed using commercially available LAAO devices in accordance with the device's instruction for use (IFU).

Locations (19)

Grandview Medical Center

Birmingham, Alabama, United States

Tucson Medical Center

Tucson, Arizona, United States

Pima Heart and Vascular

Tucson, Arizona, United States

Washington Regional Medical Center

Fayetteville, Arkansas, United States

Arrhythmia Research Group

Jonesboro, Arkansas, United States

Marin General Hospital

Larkspur, California, United States

Hoag Memorial Hospital

Newport, California, 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

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

The Kansas City Heart Rhythm Institute

Overland Park, Kansas, United States

Saint Elizabeth Medical Center

Edgewood, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Albert Einstein College Of Medicine - Montefiore Medical Center

The Bronx, New York, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Mercy Hospital

Janesville, Wisconsin, United States