An interventional study of VARIPULSE Catheter System (PVI) and VARIPULSE Catheter System (PVI and PWI) in Atrial Fibrillation, sponsored by Biosense Webster, Inc.. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Biosense Webster, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
Among 71 studies in Atrial Fibrillation by Johnson & Johnson — 7 open to participants now, 12 under way, 1 of them phase 3. Atrial Fibrillation · Johnson & Johnson.
Among the 71 studies in Atrial Fibrillation by Johnson & Johnson, this one is the 3rd largest by planned enrollment of the 58 interventional ones that give a count, is the only one that started in 2027, is one of 34 with no phase, reaches primary completion later than 10 of the 11 other live ones, and was the 70th registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.
Browse Atrial Fibrillation studies →7 of the 71 studies in Atrial Fibrillation by Johnson & Johnson are open now, in 5 countries. Recruiting first, the newest first:
Biosense Webster, Inc. · Sites in China
Ages 18–80
Johnson & Johnson Medical (Shanghai) Ltd. · Sites in China
Ages 18–80
Biosense Webster, Inc. · Sites in United States
Ages 18–80
Biosense Webster, Inc. · Sites in United States
Ages 18–80
Biosense Webster, Inc. · Sites in United States
Ages 22+
By country, each count listing its studies:
Of the 611 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 43 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
71 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 12 · Phase 4 10
First in 2003; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 2,300 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Median enrollment 149 across the 58 interventional studies, 426 across the 13 observational. Of the 57 that completed or were terminated, 39 (68%) have results posted.
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This study is registered under Biosense Webster, Inc., one of the names counted as Johnson & Johnson. Under that name alone:
Biosense Webster, Inc. is the lead sponsor of 64 studies on the registry; 8 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 24 (92%) have results posted.
6 of the studies in Atrial Fibrillation by Johnson & Johnson that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05757869Phase 3Janssen Research & Development, LLCA Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation | 2026-12-08 |
| NCT07429214Biosense Webster, Inc.A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF | 2026-12-30 |
| NCT07428564Biosense Webster, Inc.A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF | 2026-12-30 |
| NCT03963349Biosense Webster, Inc.THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study | 2026-12-31 |
| NCT07116525Biosense Webster, Inc.A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter | 2027-02-07 |
Add all 6 to your calendar (.ics) → With an account.
Among the 71 studies in Atrial Fibrillation by Johnson & Johnson, from their registry updates:
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The purpose of this study is to evaluate how safe VARIPULSE™ Catheter is and how well it works in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and symptomatic persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts more than 7 days and doesn't stop on its own).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participant has been diagnosed with either atrial fibrillation (AF) subtype (paroxysmal (AF episodes that start suddenly and typically last less than 7 days, often resolving in 24 hours) or persistent (AF lasting more than 7 days in duration and less than 365 days in duration, documented by )):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with symptomatic paroxysmal atrial fibrillation (PAF) undergoing first-time catheter ablation will be enrolled; and will undergo pulmonary vein isolation (PVI) utilizing the VARIPULSE catheter as per the device Instructions for Use (IFU).
Device: VARIPULSE Catheter System (PVI)
Participants with symptomatic persistent atrial fibrillation (PsAF) undergoing first-time catheter ablation will be enrolled; and will undergo pulmonary vein isolation (PVI) and posterior wall isolation (PWI) utilizing the VARIPULSE catheter as per the device IFU.
Device: VARIPULSE Catheter System (PVI and PWI)
VARIPULSE™ Catheter System that is the VARIPULSE™ Catheter, TRUPULSE™ Generator, and a Sterile Interface Cable in conjunction with the CARTO™ 3 System with PFA Support for VARIPULSE™ Catheter Software Module with VARIPULSE™ Pro License will be used for ablation procedure.
VARIPULSE™ Catheter System that is the VARIPULSE™ Catheter, TRUPULSE™ Generator, and a Sterile Interface Cable in conjunction with the CARTO™ 3 System with PFA Support for VARIPULSE™ Catheter Software Module with VARIPULSE™ Pro License will be used for ablation procedure.
Number of Participants with Early Onset Primary Adverse Events (PAEs)
PAEs include early onset AEs such as: * Esophageal perforating complications * Phrenic nerve paralysis (PNP; permanent) * Cardiac tamponade/perforation * Pulmonary vein stenosis (PVS) * Death (device or procedure related) * Stroke/ cerebrovascular accident (CVA) * Major vascular access complication/bleeding * Thromboembolism * Myocardial Infarction (MI) * Transient ischemic attack (TIA) * Pericarditis * Pulmonary edema (respiratory insufficiency) * Heart block * Vagal nerve injury/ gastroparesis
Time frame: Up to 7 days post-procedure
Percentage of Participants With Residual Atrial Arrhythmia (AA) Burden Based on ILR Arrhythmia Monitoring
Percentage of residual AA burden will be calculated as AA episodes over the monitoring time during the effectiveness evaluation period. Participants with residual AA burden less than or equal to (\<=) 0.1% and freedom from the following failure modes will be considered a success * Acute procedural failure * Repeat ablation failure * Surgical treatment for atrial fibrillation (AF)/atrial tachycardia (AT)/atrial flutter (AFL) after the index ablation procedure * Non-study catheter (NSC) failure * Antiarrhythmic Drug (AAD) failure or any direct current (DC) cardioversion (DCCV) procedure during the evaluation period.
Time frame: Day 61 up to Day 365 post-procedure
Change in Quality of Life (QOL) As Assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score
The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" difficult to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). A positive change in score corresponds to improvement in AF symptoms.
Time frame: Baseline to 12 months post-procedure
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes (12-Lead ECG or >=60 minutes on Implantable Loop Recorders [ILR])
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT or AFL of unknown origin+) episodes based on electrocardiographic data (12-Lead ECG or \>=60 minutes on ILR arrhythmia monitoring) during the post-blanking period will be reported.
Time frame: Day 61 up to Day 365 post-procedure
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes (12-Lead ECG or >=30 seconds on ILR)
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT or AFL of unknown origin+) episodes based on electrocardiographic data (12-Lead ECG or \>=30 seconds on ILR arrhythmia monitoring) during the post-blanking period.
Time frame: Day 61 up to Day 365 post-procedure
Number of Participants with Residual AA Burden <=0.1%
Number of participants with residual AA burden \<=0.1% in the post-blanking period, without any additional failure modes will be reported.
Time frame: Day 61 up to Day 365 post-procedure
Percentage of Residual AA Burden
Percentage of residual AA burden in the post-blanking period without any additional failure modes will be reported.
Time frame: Day 61 up to Day 365 post-procedure
No study locations are listed for this record.
Plan to share: 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
Data sharing details ↗ · www.jnj.com
No publications or documents are linked to this record.
Start is estimated for Apr 2027; primary completion for Oct 2029, 30 months later.
Of 255 industry-sponsored interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's planned 30 months is above that.
Counting every sponsor, half of 1,050 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 3, 2026: start Oct 2026 → Apr 2027 and completion Oct 2029 → Mar 2030.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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