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A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

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

NCT07428564•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 persistent atrial fibrillation (PsAF; irregular, rapid heart rhythm that lasts over 7 days and doesn't stop on its own).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosed with symptomatic persistent atrial fibrillation (PsAF)
•Selected to undergo an ablation procedure for management of their arrhythmia by pulmonary vein isolation (PVI) +
•Failed at least one antiarrhythmic drug (AAD; class I to IV) as evidenced by recurrent symptomatic atrial fibrillation (AF), or intolerable or contraindicated to the AAD
•Age 18-75 years
•Willing and capable of providing consent
•Able and willing to comply with all pre-, post- and follow-up testing and requirements

Exclusion Criteria

•Continuous AF greater than (\>) 12 months (1-Year) (Longstanding Persistent AF)
•Previous surgical or catheter ablation for atrial fibrillation
•Any cardiac surgery within the past 2 months (60 days prior to consent date) (includes percutaneous coronary intervention \[PCI\])
•Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (for example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure
•Any carotid stenting or endarterectomy
•Presence of left atrium (LA) thrombus
•Severe dilatation of the LA (left atrial diameter (LAD) \> 50 millimeter \[mm\] antero-posterior diameter in case of transthoracic echocardiography \[TTE\])
•Severely compromised left ventricular ejection fraction (LVEF less than \[\<\] 40%)
•Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study
•Prior diagnosis of pulmonary vein stenosis
+24 more criteria

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

Policlinico Tor Vergata

Roma, Italy

IRCCS Policlinico San Donato

San Donato Milanese, Italy

Vilnius University Hospital Santaros Clinics

Vilnius, Lithuania

Erasmus MC

Rotterdam, Netherlands

Key Dates

Start Date

March 1, 2026

Primary Completion Date

December 30, 2026

Completion Date

December 30, 2026

Last Updated

March 13, 2026

Enrollment

ESTIMATED participants

Conditions

Atrial Fibrillation

Interventions

Pulsed Field Ablation System

DEVICE

Contacts

Wannes Vermander

CONTACT

+32 494 03 08 40 wverman1@ITS.JNJ.com

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The Fourth Left Atrial Appendage Occlusion Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

The CONFORM Pivotal Trial

Artificial Intelligence Mapping and Ablation of Non-Pulmonary Vein Electrical Drivers of AF Study

The Fourth Left Atrial Appendage Occlusion Study

The CoAGulation Biomarkers and Atrial Fibrillation (COAG-AF) Pilot Study

Medtronic Terminate AF Study

cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia