Atrial FibrillationAdmIREPASNCT07227532
A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System
A study testing Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 23 sites in United States.
Trial summary
The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 23 sitesUnited States
- Study dates
- 21 Oct 2025to 31 Dec 2030
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF
- Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD)
- Willing and capable of providing consent
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Who cannot join
- Previously diagnosed with persistent or long-standing persistent AF (more than [>] 7 days in duration)
- Previous surgical or catheter ablation for AF
- Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF
- Current enrollment in an investigational study evaluating another device or drug
- Life expectancy less than 12 months
- Any contraindications as defined in the Protocol
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
United States23 sites, 23 recruiting
- Recruiting
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012
- Recruiting
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45229
- Recruiting
Baylor Scott and White Research Institute
Fort Worth, Texas, 76104
- Recruiting
OC Memorial
Fountain Valley, California, 92708
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
- Recruiting
Mercy Hospital
Janesville, Wisconsin, 53548
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
- Recruiting
Northwell Health Physician Partners Cardiology
Lake Success, New York, 11042
- Recruiting
HCA Florida Mercy Hospital
Miami, Florida, 33133
- Recruiting
Edward Hospital Midwest Cardiovascular Institute
Naperville, Illinois, 60540
- Recruiting
Orlando Health Heart and Vascular Institute
Orlando, Florida, 32806
- Recruiting
The Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211
- Recruiting
Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85018
- Recruiting
Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
Plano, Texas, 75093
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
- Recruiting
Springfield Medical Center
Springfield, Ohio, 45504
- Recruiting
Albert Einstein College Of Medicine - Montefiore Medical Center
The Bronx, New York, 10467
- Recruiting
Tucson Medical Center Pima Heart and Vascular
Tucson, Arizona, 85704
- Recruiting
Community Memorial Hospital
Ventura, California, 93003
- Recruiting
Winchester Medical Center
Winchester, Virginia, 22601
- Recruiting
Trinity Health
Ypsilanti, Michigan, 48197
About this study
Official title: BWI202405: Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System
The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).
- Conditions
- Atrial Fibrillation
- Being tested
- Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
- 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 by VARIPULSE Catheter with TRUPULSE GeneratorDevice
Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator | Experimental | Participants undergoing electrophysiology mapping and pulsed field ablation (PFA) for management of treatment of symptomatic paroxysmal atrial fibrillation (AF) will undergo pulmonary vein (PV) ablation with the VARIPULSE Catheter with a TRUPULSE Generator. Receives: Device: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure
PAE's will include the following adverse events: atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.
Measured: Within 7 days post index procedure
Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episodes
Freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmias (atrial fibrillation [AF], atrial tachycardia [AT] or atrial flutter [AFL] of unknown origin) episodes will be reported. AFL of unknown origin is defined as all AFL except those Cavotricuspid isthmus CTI dependent AFL as confirmed by 12-Lead electrocardiogram (ECG) and entrainment maneuvers in an evaluation period study.
Measured: Day 61-1095 post-index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start21 Oct 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (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.
- 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
- 276 participants (estimated)
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
- NCT07227532
- Sponsor's protocol ID
- BWI202405
- Other IDs
- BWI202405
- Acronym
- AdmIREPAS
- Status last verified
- Sep 2026
- First submitted
- 11 Nov 2025
- Last updated
- 30 Sep 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 Innovative Medicine 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BWI202405: Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System
- ClinicalTrials.gov ID
- NCT07227532
- Acronym / sponsor ID
- AdmIREPAS / BWI202405
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 12 Nov 2025 (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 purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).
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 by VARIPULSE Catheter with TRUPULSE Generator | Experimental | Device: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE GeneratorParticipants undergoing electrophysiology mapping and pulsed field ablation (PFA) for management of treatment of symptomatic paroxysmal atrial fibrillation (AF) will undergo pulmonary vein (PV) ablation with the VARIPULSE Catheter with a TRUPULSE Generator. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF
- Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD)
- Willing and capable of providing consent
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Key exclusion criteria (6 listed)
- Previously diagnosed with persistent or long-standing persistent AF (more than [>] 7 days in duration)
- Previous surgical or catheter ablation for AF
- Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF
- Current enrollment in an investigational study evaluating another device or drug
- Life expectancy less than 12 months
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 by VARIPULSE Catheter with TRUPULSE GeneratorPulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used. | Device | Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator |
Primary outcome
Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure
Time frame: Within 7 days post index procedure
PAE's will include the following adverse events: atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.
Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episodes
Time frame: Day 61-1095 post-index procedure
Freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmias (atrial fibrillation [AF], atrial tachycardia [AT] or atrial flutter [AFL] of unknown origin) episodes will be reported. AFL of unknown origin is defined as all AFL except those Cavotricuspid isthmus CTI dependent AFL as confirmed by 12-Lead electrocardiogram (ECG) and entrainment maneuvers in an evaluation period study.
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 30 Sep 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine 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.
Biosense Webster, Inc. Clinical Trial study director
Biosense Webster, Inc.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 23 sites in United States.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. 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?
Contact Emily Purcell (+1 949 230 3701, EPurcel1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure (time frame: Within 7 days post index procedure). The study lists 2 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 30 Sep 2026.