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

NCT07429214 | Recruiting FDA Device

• 1 other identifier: BWI202525
• Study Type: interventional
• Target: 50
• Locations: 7 countries
• Sites: 10

Brief 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).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (9)

• Total Procedure Time

  The total procedure time will be reported.

  Intraoperative

• Pulsed Field (PF) Application Time

  The PF application time will be reported.

  Intraoperative

• Number of PF applications by Pulmonary Vein (PV)

  Number of PF applications by PV will be reported.

  Intraoperative

• Number of PF applications by Other Cardiac Locations

  Number of PF applications by other cardiac locations will be reported.

  Intraoperative

• Number of PF applications by Participant

  Number of PF applications by participant will be reported.

  Intraoperative

• Pulmonary Vein Isolation (PVI) Time

  Time to PVI will be reported.

  Intraoperative

• Total Fluoroscopy Time

  The total time that fluoroscopy/ X-Ray system used during the ablation procedure will be reported.

  Intraoperative

• Total Study Catheter Left Atrial Dwell Time

  The total study catheter left atrial dwell time (that is time between the ablation catheter entering the left atrium to its withdrawal from the left atrium) will be reported.

  Intraoperative

• Acute Effectiveness

  Acute procedural success, which is defined as electrical isolation of clinically relevant targeted PVs (confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure will be reported.

  Intraoperative

Secondary Outcomes (5)

• Occurrence of Serious Adverse Device Effects (SADE; Within Seven [7] Days of Index Ablation Procedure) Where the Investigational Devices were Used per Clinical Investigation Plan

  Up to 7 days post index ablation procedure

• Occurrence of Unanticipated Serious Adverse Device Effects (USADEs)

  Up to 3 months post index ablation procedure

• Occurrence of SAEs

  At 7 days, 8 to 30 days (peri-procedural) and Up to 3 months post index ablation procedure

• Occurrence of Non-Serious Adverse Events (Non-SAEs)

  Up to 3 months post index ablation procedure

• Number of Participants with PVI Durability

  Up to 90 days post index ablation procedure

Study Arms (1)

Pulsed Field Ablation: VARIPULSE Catheter with TRUPULSE Generator and VARIPULSE Pro Software

EXPERIMENTAL

Participants undergoing cardiac ablation for management of treatment of symptomatic Persistent Atrial Fibrillation (PsAF) or Paroxysmal Atrial Fibrillation (PAF) will undergo pulsed field ablation (PFA) with the VARIPULSE Catheter and the TRUPULSE Generator with the new VARIPULSE Pro software.

Device: Pulsed Field Ablation System

Interventions

Pulsed Field Ablation System DEVICE

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

Pulsed Field Ablation: VARIPULSE Catheter with TRUPULSE Generator and VARIPULSE Pro Software

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with symptomatic persistent atrial fibrillation (PsAF) or paroxysmal atrial fibrillation (PAF)
• Selected to undergo an ablation procedure for management of their arrhythmia by pulmonary vein isolation (PVI) only or PVI only with cavotricuspid isthmus (CTI) dependent atrial flutter ablation
• 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

You may not qualify if:

• 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 millimeters \[mm\] antero-posterior diameter in case of transthoracic echocardiography \[TTE\])
• Severely compromised left ventricular ejection fraction (LVEF less than \[\<\] 40 percent \[%\])
• 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
• Pre-existing hemi diaphragmatic paralysis
• History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
• Myocardial infarction (MI) within the past 2 months (60 days prior to consent date)
• Documented thromboembolic event (including transient ischemic attack \[TIA\]) within the past 6 months \[180 days prior to consent date\])
• Rheumatic Heart Disease

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (10)

AZORG campus Aalst Moorselbaan

Aalst, 9300, Belgium

NOT YET RECRUITING

A.Z. Sint Jan

Bruges, 8000, Belgium

NOT YET RECRUITING

Aarhus University Hospital

Aarhus N, 8200, Denmark

NOT YET RECRUITING

Hospices Civils de Lyon HCL

Bron, 69500, France

NOT YET RECRUITING

Institut Medico chirurgical Montsouris

Paris, 75014, France

NOT YET RECRUITING

University Hospital of the Ruhr-University of Bochum

Bad Oeynhausen, 32545, Germany

NOT YET RECRUITING

Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata'

Roma, 00133, Italy

NOT YET RECRUITING

IRCCS Policlinico San Donato

San Donato Milanese, 20097, Italy

NOT YET RECRUITING

Vilnius University Hospital Santaros Clinics

Vilnius, 08406, Lithuania

RECRUITING

Erasmus MC

Rotterdam, 3015, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Biosense Webster, Inc. Clinical Trial

  Biosense Webster, Inc.

  STUDY DIRECTOR

Central Study Contacts

Nathalie Macours

CONTACT

+32 2 746 30 76; nmacours1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

BE (2); FR (2); DE (1); IT (2); DK (1); LI (1); NL (1)