Atrial FibrillationVP-EXTRANCT07428564
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF
A study testing Pulsed Field Ablation System in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 6 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pulsed Field Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 19 May 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 34Show fewer
- 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, implantable pacemakers, implantable cardioverter/defibrillators (ICDs),etc. (at PI discretion)
- Presence of iron-containing metal fragments in the body
- Unresolved pre-existing neurological deficit
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Belgium2 sites
AZORG campus Aalst Moorselbaan
Aalst, 9300
A.Z. Sint Jan
Bruges, 8000
Germany1 site
University Hospital of the Ruhr-University of Bochum
Bad Oeynhausen, 32545
About this study
Official title: 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)
- Conditions
- Atrial Fibrillation
- Being tested
- Pulsed Field Ablation System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Field Ablation SystemDevice
Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator along with VARIPULSE Pro software will be used.
| Study group | Role | What they receive |
|---|---|---|
| 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) will undergo pulsed field ablation (PFA) with the VARIPULSE Catheter and the TRUPULSE Generator with the new VARIPULSE Pro software. Receives: Device: Pulsed Field Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Procedural Success
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.
Measured: Intraoperative
Pulmonary Vein Isolation (PVI) Durability
PVI durability is defined as 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 (+/- 14 days) post index ablation procedure.
Measured: Up to 3 months post index ablation procedure
Pulsed Field (PF) Applications Time
PF applications time will be reported.
Measured: Intraoperative
Number of PF applications
Number of PF applications will be reported.
Measured: Intraoperative
Tissue Proximity Indication (TPI)
TPI will be reported.
Measured: Intraoperative
Secondary outcomes (12)
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.
Measured: Up to 7 days post index ablation procedure
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.
Measured: Up to 3 months 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 ife-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.
Measured: 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)
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.
Measured: Up to 3 months post index ablation procedure
Occurrence of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by Magnetic Resonance Imaging (MRI) Evaluations
Occurrence of new post-ablation asymptomatic and symptomatic cerebral emboli will be evaluated using cerebral MRI performed post-ablation.
Measured: Post-ablation (within 72 hours after ablation) and up to 3 months post index ablation procedure
Anatomical Location of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by MRI Evaluations
Anatomical location of new post-ablation asymptomatic and symptomatic cerebral emboli will be evaluated using cerebral MRI performed post-ablation.
Measured: Post-ablation (within 72 hours after ablation) and up to 3 months post index ablation procedure
Size of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by Magnetic Resonance Imaging (MRI) Evaluations
Size of new post-ablation asymptomatic and symptomatic cerebral emboli will be evaluated using cerebral MRI performed post-ablation.
Measured: Post-ablation (within 72 hours after ablation) and up to 3 months post index ablation procedure
Occurrence of New or Worsening Neurological Deficits
Occurrence of new or worsening neurological deficits will be assessed.
Measured: Post-ablation (within 72 hours after ablation) and up to 3 months post index ablation procedure
Mini Mental State Examination (MMSE) Total Score
The MMSE is a, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.
Measured: Baseline (within 72 hours prior to ablation), and post-ablation (72 hours after ablation procedure)
National Institutes of Health Stroke Scale (NIHSS) Score
The NIHSS is a clinician-reported measure of neurological deficit with scores ranging from 0 to 42. No stroke symptoms (0), mild stroke (1-4), moderate stroke (5-15), moderate to severe stroke (16-20), and sever (21-42).
Measured: Baseline (within 72 hours pre ablation procedure), and post-ablation (72 hours after ablation procedure)
Modified Rankin Scale (mRS) Scale Score
The mRS score is a validated score measuring neurologic outcomes after cardio-pulmonary resuscitation (CPR) where:
- mRS 0: No symptoms.
- mRS 1: No significant disability. Able to perform all usual activities, despite some symptoms.
- mRS 2: Slight disability. Independent but unable to perform usual activities (work, sports, leisure).
- mRS 3. Moderate disability. Requires assistance, but able to walk alone.
- mRS 4: Moderately severe disability. Walking assistance and/or daily living activities not possible.
- mRS 5. Major disability. Bedridden, incontinent and requires constant nursing care and attention.
- mRS 6: Death.
Measured: Baseline (within 72 hours pre ablation procedure), and post-ablation (72 hours after ablation procedure)
Occurrence of Severe Pulmonary Vein (PV) Stenosis
Occurrence of severe PV stenosis as determined by Computed Tomography (CT)/ Magnetic Resonance Angiogram (MRA) evaluations will be reported.
Measured: Up to 3 months post index ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start19 May 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Biosense Webster, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosense Webster, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Biosense Webster, Inc. Clinical Trial, Study director, Biosense Webster, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428564
- Sponsor's protocol ID
- BWI202513
- Other IDs
- BWI202513
- Acronym
- VP-EXTRA
- Status last verified
- Nov 2026
- First submitted
- 19 Feb 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Workflow Study of the VARIPULSE™ Catheter With the TRUPULSE™ Generator for Treatment of Persistent Atrial Fibrillation (PsAF) With the New VARIPULSE™ Pro Software
- ClinicalTrials.gov ID
- NCT07428564
- Acronym / sponsor ID
- VP-EXTRA / BWI202513
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 May 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulsed Field Ablation: VARIPULSE Catheter with TRUPULSE Generator and VARIPULSE Pro Software | Experimental | Device: Pulsed Field Ablation SystemParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Field Ablation SystemPulsed field ablation by VARIPULSE catheter with TRUPULSE generator along with VARIPULSE Pro software will be used. | Device | Pulsed Field Ablation: VARIPULSE Catheter with TRUPULSE Generator and VARIPULSE Pro Software |
Primary outcome
Acute Procedural Success
Time frame: Intraoperative
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.
Pulmonary Vein Isolation (PVI) Durability
Time frame: Up to 3 months post index ablation procedure
PVI durability is defined as 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 (+/- 14 days) post index ablation procedure.
Pulsed Field (PF) Applications Time
Time frame: Intraoperative
PF applications time will be reported.
Number of PF applications
Time frame: Intraoperative
Number of PF applications will be reported.
Tissue Proximity Indication (TPI)
Time frame: Intraoperative
TPI will be reported.
12 secondary outcomes
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
Occurrence of Unanticipated Serious Adverse Device Effects (USADEs)
Time frame: 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
Occurrence of Non-Serious Adverse Events (Non-SAEs)
Time frame: Up to 3 months post index ablation procedure
Occurrence of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by Magnetic Resonance Imaging (MRI) Evaluations
Time frame: Post-ablation (within 72 hours after ablation) and up to 3 months post index ablation procedure
Anatomical Location of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by MRI Evaluations
Time frame: Post-ablation (within 72 hours after ablation) and up to 3 months post index ablation procedure
Size of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by Magnetic Resonance Imaging (MRI) Evaluations
Time frame: Post-ablation (within 72 hours after ablation) and up to 3 months post index ablation procedure
Occurrence of New or Worsening Neurological Deficits
Time frame: Post-ablation (within 72 hours after ablation) and up to 3 months post index ablation procedure
Mini Mental State Examination (MMSE) Total Score
Time frame: Baseline (within 72 hours prior to ablation), and post-ablation (72 hours after ablation procedure)
National Institutes of Health Stroke Scale (NIHSS) Score
Time frame: Baseline (within 72 hours pre ablation procedure), and post-ablation (72 hours after ablation procedure)
Modified Rankin Scale (mRS) Scale Score
Time frame: Baseline (within 72 hours pre ablation procedure), and post-ablation (72 hours after ablation procedure)
Occurrence of Severe Pulmonary Vein (PV) Stenosis
Time frame: Up to 3 months post index ablation procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biosense Webster, Inc. Clinical Trial study director
Biosense Webster, Inc.
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Field Ablation System in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Denmark, Germany, Italy, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Procedural Success (time frame: Intraoperative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.