A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF (VP-CONFIRM)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Pulsed Field Ablation System

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathalie Macours; Phone Number: +32 2 746 30 76; Email: nmacours1@its.jnj.com

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Not yet recruiting
    • AZORG campus Aalst Moorselbaan
  • Bruges, Belgium, 8000
    • Not yet recruiting
    • A.Z. Sint Jan
• Denmark
  • Aarhus N, Denmark, 8200
    • Not yet recruiting
    • Aarhus University Hospital
• France
  • Bron, France, 69500
    • Not yet recruiting
    • Hospices Civils de Lyon HCL
  • Paris, France, 75014
    • Not yet recruiting
    • Institut Medico chirurgical Montsouris
• Germany
  • Bad Oeynhausen, Germany, 32545
    • Not yet recruiting
    • University Hospital of the Ruhr-University of Bochum
• Italy
  • Roma, Italy, 00133
    • Not yet recruiting
    • Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata'
  • San Donato Milanese, Italy, 20097
    • Not yet recruiting
    • IRCCS Policlinico San Donato
• Lithuania
  • Vilnius, Lithuania, 08406
    • Recruiting
    • Vilnius University Hospital Santaros Clinics
• Netherlands
  • Rotterdam, Netherlands, 3015
    • Not yet recruiting
    • Erasmus MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• 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

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 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
• Uncontrolled heart failure or New York heart association (NYHA) function class III or IV
• Severe mitral regurgitation
• Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
• Unstable angina pectoris within the past 6 months prior to consent date
• Acute illness or active systemic infection or sepsis
• Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity [Body Mass Index >40 kilogram per meter square {kg/m^2}], renal insufficiency (with an estimated creatinine clearance < 30 milliliters per minute {mL/min}/1.73 m^2)
• Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch, prosthetic valve or other abnormality that precludes catheter introduction or manipulation
• Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter
• Presence of any other condition that precludes appropriate vascular access (such as inferior vena cava [IVC] filter)
• Significant pulmonary disease, (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease [COPD]) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
• Significant congenital anomaly or medical problems that in the opinion of the investigator would preclude enrollment in this study
• Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation
• Current enrollment in an investigational study evaluating another device, biologic, or drug
• Presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (IFU)
• Categorized as vulnerable population and requiring special treatment with respect to safeguards of well-being
• Life expectancy less than 12 months
• Contraindication for MRI such as use of contrast agents due to advanced renal disease, claustrophobia etc. (at principal investigator [PI] discretion)
• Presence of iron-containing metal fragments in the body
• Unresolved pre-existing neurological deficit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pulsed Field Ablation: VARIPULSE Catheter with TRUPULSE Generator and VARIPULSE Pro Software; 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; Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator along with VARIPULSE pro software will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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
Total Fluoroscopy Time	The total time that fluoroscopy/ X-Ray system used during the ablation procedure 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Unanticipated Serious Adverse Device Effects (USADEs)	An USADE is any SAE on health, safety, any life-threatening problem, or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, outcome, or degree of incidence in the current investigational plan or risk analysis report, or any other unanticipated serious problem associated with a device that relates to rights, safety, or welfare of participants.	Up to 3 months post index ablation procedure
Occurrence of Non-Serious Adverse Events (Non-SAEs)	An Adverse Event (AE) means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in participants, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.	Up to 3 months post index ablation procedure
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	A SADE is an adverse device effect that has resulted in any of the consequences characteristic of an serious adverse event (SAE). A SAE is any event that led to any of the following: Death, Serious deterioration in the health of a participant that resulted in any of the following: life-threatening illness or injury, permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of patient hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function, chronic disease and fetal distress, fetal death or a congenital physical or mental impairment or birth defect.	Up to 7 days post index ablation procedure
Occurrence of SAEs	An SAE is any event that led to any of the following: Death, Serious deterioration in the health of a participant that resulted in any of the following: life-threatening illness or injury, permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of patient hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function, chronic disease and fetal distress, fetal death or a congenital physical or mental impairment or birth defect.	At 7 days, 8 to 30 days (peri-procedural) and Up to 3 months post index ablation procedure
Number of Participants with PVI Durability	PVI durability is defined as a sustained isolations of PVs that are targeted in the index ablation procedure, which is evidenced by the confirmation of isolation via the electro-anatomical mapping 90 days (+/- 14 days) post index ablation procedure.	Up to 90 days post index ablation procedure

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Study Director: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: BWI202525 (Other Identifier: Biosense Webster, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson MedTech is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes