An interventional study of VARIPULSE Catheter System and LAAO Device in Atrial Fibrillation, sponsored by Biosense Webster, Inc.. Recruiting at 13 sites in United States. 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
The purpose of this study is to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat heart rhythm disease). This includes isolation of pulmonary vein and superior vena cava (heart veins; pulmonary vein isolation [PVI] and superior vena cava isolation [SVCI]), with or without another technique called posterior wall isolation (PWI). Also, to assess how safe it is for participants who are having a catheter ablation procedure and at the same time receiving another procedure called left atrial appendage occlusion (LAAO; to reduce stroke risk). Additionally, to assess how well VARIPULSE catheter system works over a long period of time for treatment of PsAF in participants undergoing catheter ablation for PVI, SVCI and SVCI+PWI.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 1,070 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →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.
Counted across the registry records on this site, refreshed daily.
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.
Left atrial appendage occlusion (LAAO) concomitant subset:
- Participant is clinically indicated for a LAAO procedure
Exclusion criteria:
LAAO concomitant subset:
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 persistent atrial fibrillation (PsAF) undergoing catheter ablation for the first-time with the VARIPULSE Catheter System will undergo the ablation procedure for PVI and SVCI. Additionally, a subset of participants will undergo a concomitant left atrial appendage occlusion (LAAO) procedure. All participants will be followed for up to 36 months post procedure.
Device: VARIPULSE Catheter System · Device: LAAO Device
Participants with PsAF undergoing catheter ablation for the first-time with VARIPULSE catheter system will undergo the ablation procedure for PVI and SVCI along with posterior wall isolation (PWI). Additionally, a subset of participants will undergo a concomitant LAAO procedure. All participants will be followed for up to 36 months post procedure.
Device: VARIPULSE Catheter System · Device: LAAO Device
Pulsed field ablation by VARIPULSE Catheter System (VARIPULSE bi-directional catheter and TRUPULSE generator) will be used.
LAAO procedures will be performed using commercially available LAAO devices in accordance with the device's instruction for use (IFU).
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, and vagal nerve injury/ gastroparesis.
Time frame: Up to approximately 7 days post-procedure
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (that is, atrial fibrillation or atrial tachycardia or atrial flutter \[AF, AT or AFL\] of unknown origin) episodes based on electrocardiographic data and freedom from acute procedural failure, repeat ablation failure, surgical treatment for AF/AT/AFL, non-study catheter (NSC) failure, antiarrhythmic drug (AAD) failure and any direct current (DC) cardioversion procedure.
Time frame: Day 61 up to Day 180
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (that is, AF, AT or AFL of unknown origin) episodes based on electrocardiographic and freedom from acute procedural failure, repeat ablation failure, surgical treatment for AF/AT/AFL, NSC failure, AAD failure and any DC cardioversion (DCCV) procedure.
Time frame: Day 61 up to Day 365
Change From Baseline in Quality of life, As Measured by the Total 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, at 12 months post-procedure
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 ↗ · innovativemedicine.jnj.com
No publications or documents are linked to this record.
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 ↗
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