RecruitingNot ApplicableNCT07523750

A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation

Comparison of Safety and Effectiveness of a VARIPULSE™ PFA Catheter to FARAWAVE™ PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation: A Randomized Controlled Trial

Sponsor

Biosense Webster, Inc.

Enrollment

566 participants

Start Date

Apr 2, 2026

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

Summary

The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called FARAWAVE Catheter and a medical device called VARIPULSE Catheter for people with atrial fibrillation. The study is currently recruiting participants at 11 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEVARIPULSE Catheter

Pulsed Field Ablation using the VARIPULSE catheter.

DEVICEFARAWAVE Catheter

Pulsed field ablation using the FARAWAVE catheter.

Locations(10)

Arrhythmia Research Group

Jonesboro, Arkansas, United States

OC Medical Center

Fountain Valley, California, United States

Community Memorial Hospital

Ventura, California, United States

NCH Healthcare

Naples, Florida, United States

Lenox Hill Hospital

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

WakeMed Hospital

Raleigh, North Carolina, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Baylor Research Institute

Plano, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07523750

Related Trials

Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures

NCT072712381 location

Anatomical Navigation for Guided Electrophysiology in AFL and AFib

NCT072101512 locations

Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation 2

NCT0713931437 locations

Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation

NCT051152142 locations

Safety and Performance of the SpherePVI™ Catheter to Treat Paroxysmal Atrial Fibrillation

NCT051445031 location