A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF (VP-EXTRA)

June 4, 2026 updated by: Biosense Webster, Inc.

Workflow Study of the VARIPULSE™ Catheter With the TRUPULSE™ Generator for Treatment of 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 persistent atrial fibrillation (PsAF; irregular, rapid heart rhythm that lasts over 7 days and doesn't stop on its own).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  • Pre-existing hemi diaphragmatic paralysis
  • History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
  • 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 squared [kg/m^2]), renal insufficiency (with an estimated creatinine clearance < 30 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 instruction 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 PI discretion)
  • Presence of iron-containing metal fragments in the body
  • Unresolved pre-existing neurological deficit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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) 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Procedure Time
Time Frame: Intraoperative
The total procedure time will be reported.
Intraoperative
Pulsed Field (PF) Application Time
Time Frame: Intraoperative
The PF application time will be reported.
Intraoperative
Number of PF applications by Pulmonary Vein (PV)
Time Frame: Intraoperative
Number of PF applications by PV will be reported.
Intraoperative
Number of PF applications by Other Cardiac Locations
Time Frame: Intraoperative
Number of PF applications by other cardiac locations will be reported.
Intraoperative
Number of PF applications by Participant
Time Frame: Intraoperative
Number of PF applications by participant will be reported.
Intraoperative
Pulmonary Vein Isolation (PVI) Time
Time Frame: Intraoperative
Time to PVI will be reported.
Intraoperative
Total Fluoroscopy Time
Time Frame: Intraoperative
The total time that fluoroscopy/ X-Ray system was used during the ablation procedure will be reported.
Intraoperative
Total Study Catheter Left Atrial Dwell Time
Time Frame: Intraoperative
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
Time Frame: Intraoperative
Acute effectiveness, that is, 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Up to 7 days post index ablation procedure
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 Unanticipated Serious Adverse Device Effects (USADEs)
Time Frame: Up to 3 months post index ablation procedure
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 SAEs
Time Frame: At 7 days, 8 to 30 days (peri-procedural) and up to 3 months post index ablation procedure
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
Occurrence of Non-Serious Adverse Events (Non-SAEs)
Time Frame: Up to 3 months post index ablation procedure
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
PVI Durability
Time Frame: Up to 90 days post index ablation procedure
PVI durability is defined as a sustained isolation 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 post index ablation procedure.
Up to 90 days post index ablation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biosense Webster, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BWI202513 (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 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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