RecruitingNot ApplicableNCT07428564

A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF

Workflow Study of the VARIPULSE™ Catheter With the TRUPULSE™ Generator for Treatment of Persistent Atrial Fibrillation (PsAF) With the New VARIPULSE™ Pro Software

Sponsor

Biosense Webster, Inc.

Enrollment

50 participants

Start Date

May 19, 2026

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

Summary

The main purpose of this study is to investigate the workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE catheter and TRUPULSE generator) when used for cardiac ablation with the new VARIPULSE Pro software in participants with persistent atrial fibrillation (PsAF; irregular, rapid heart rhythm that lasts over 7 days and doesn't stop on its own)

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Pulsed Field Ablation System for people with atrial fibrillation. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 18 Years to 75 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.

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Interventions

DEVICEPulsed Field Ablation System

Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator along with VARIPULSE Pro software will be used.

Locations(10)

AZORG campus Aalst Moorselbaan

Aalst, Belgium

A.Z. Sint Jan

Bruges, Belgium

Aarhus University Hospital

Aarhus N, Denmark

Hospices Civils de Lyon HCL

Bron, France

Institut Medico chirurgical Montsouris

Paris, France

University Hospital of the Ruhr-University of Bochum

Bad Oeynhausen, Germany

Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata'

Roma, Italy

IRCCS Policlinico San Donato

San Donato Milanese, Italy

Vilnius University Hospital Santaros Clinics

Vilnius, Lithuania

Erasmus MC

Rotterdam, Netherlands

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NCT07428564

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