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RECRUITING
NCT07429214
NA

A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF

Sponsor: Biosense Webster, Inc.

View on ClinicalTrials.gov

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 paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days, often resolving within 24-48 hours, though sometimes lasting up to a week) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).

Official title: Workflow Study of the VARIPULSE™ Catheter With the TRUPULSE™ Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF) or Persistent Atrial Fibrillation (PsAF) With the New VARIPULSE™ Pro Software

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-03-23

Completion Date

2026-12-30

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

DEVICE

Pulsed 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