Atrial FibrillationPERSIGMA RCTNCT07523750
A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation
A study testing VARIPULSE Catheter and FARAWAVE Catheter in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 20 sites in United States.
Trial summary
The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- VARIPULSE Catheter and FARAWAVE Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- 20 sitesUnited States
- Study dates
- 2 Apr 2026to 31 May 2028
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has been diagnosed with symptomatic persistent atrial fibrillation (PsAF), which is defined as continuous atrial fibrillation (AF) sustained beyond 7 days and less than 365 days in duration documented by: i. A physician's note documenting diagnosis of symptomatic PsAF as defined above and ii. Two electrocardiograms showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be greater than [>] 365 days prior to enrollment) or iii. A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days
- Participant is aged 18 - 80 years at the time of informed consent
- Participant is willing and capable of providing informed consent
- Participant is able and willing to comply with all pre-, post- and follow-up testing and requirements
Who cannot join
- Participant has continuous AF > 365 days (longstanding persistent AF)
- Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, etc.)
- Participant has had previous surgical or catheter ablation for AF
- Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and the cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
- Participant has severe dilatation of the LA (LAD > 50 millimeters [mm]) of the antero-posterior diameter confirmed by imaging performed within 180 days prior to enrollment
- Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure
Show all 31Show fewer
- Participant has severely compromised Left Ventricular Ejection Fraction (LVEF less than [<] 40%) confirmed by imaging performed within 180 days prior to enrollment
- Participant has uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
- Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)
- Participant has had a thromboembolic event (including TIA) within the past 180 days prior to enrollment
- Participant has had a percutaneous coronary intervention or acute MI within past 60 days prior to enrollment
- Participant has had coronary artery bypass grafting (CABG) surgery within the past 180 days prior to enrollment
- Participant has had valvular cardiac surgical/percutaneous procedure (for example, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)
- Participant has unstable angina within past 6 months prior to enrollment
- Participant has anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 365 days post-procedure
- Participant has significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
- Participant has a significant congenital anomaly (for example, atrial septal defects [ASDs]) including repaired defects or medical problems that in the opinion of the Investigator would preclude enrollment in this study
- Participant has an existing diagnosis of pulmonary vein stenosis (PVS)
- Participant has a pre-existing hemi-diaphragmatic paralysis
- Participant has an acute illness, active systemic infection, or sepsis
- Participant has an intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
- Participant has severe mitral regurgitation (regurgitant volume greater than or equal to [>=] 60 milliliters [mL]/beat, regurgitant fraction >= 50 percent [%], and/or effective regurgitant orifice area >= 0.40 square centimeter [cm^2])
- Participant has an implanted metal cardiac device, including MitraClip and left atrial appendage occlusion (LAAO) devices (for example, WATCHMAN, Amulet, etcetra.) and/or a double-coiled implantable cardioverter-defibrillators (ICD), (this exclusion does not include coronary stents, implanted pacemakers, single-coiled ICD and implantable loop recorders [ILR])
- Participant has a condition that precludes vascular access (such as inferior vena cava [IVC] filter)
- Participant is currently enrolled in an investigational study evaluating another device or drug
- Participant is pregnant, lactating, or is of child-bearing potential and plans on trying to become pregnant during the course of the clinical investigation
- Participant has a life expectancy less than 365 days
- For magnetic resonance imaging (MRI) subset:
- Contraindication to use of contrast agents for MRI such as advanced renal disease etcetera
- Presence of iron-containing metal fragments in the body that renders the participant contraindicated for an MRI
- Unresolved pre-existing neurological deficit
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
- Recruiting
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
OC Medical Center
Fountain Valley, California, 92708
- Recruiting
St. Vincents Medical Center
Jacksonville, Florida, 32204
- Recruiting
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
- Recruiting
Baptist Health Lexington
Lexington, Kentucky, 40503
- Recruiting
HCA Florida Mercy Hospital
Miami, Florida, 33133
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
- Recruiting
NCH Healthcare
Naples, Florida, 34102
- Recruiting
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
- Recruiting
Baylor Research Institute
Plano, Texas, 75093
- Recruiting
WakeMed Hospital
Raleigh, North Carolina, 27610
- Recruiting
Rochester General Hospital
Rochester, New York, 14621
- Recruiting
Memorial Health University Medical Center
Savannah, Georgia, 31404
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
- Recruiting
Community Memorial Hospital
Ventura, California, 93003
- Recruiting
Trinity Health Michigan Heart - Ann Arbor Campus
Ypsilanti, Michigan, 48197
About this study
Official title: Comparison of Safety and Effectiveness of a VARIPULSE™ PFA Catheter to FARAWAVE™ PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation: A Randomized Controlled Trial
The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).
- Conditions
- Atrial Fibrillation
- Being tested
- VARIPULSE Catheter, FARAWAVE Catheter
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VARIPULSE CatheterDevice
Pulsed Field Ablation using the VARIPULSE catheter.
FARAWAVE CatheterDevice
Pulsed field ablation using the FARAWAVE catheter.
| Study group | Role | What they receive |
|---|---|---|
| VARIPULSE Pulsed Field Ablation (PFA) Catheter | Experimental | Participants with persistent atrial fibrillation (PsAF) undergoing catheter ablation will undergo the ablation procedure with VARIPULSE catheter, and will be followed for up to 12 months post procedure. Eligible participants may enter an magnetic resonance imaging (MRI) subset and undergo MRI assessments at baseline and post-ablation procedure. Receives: Device: VARIPULSE Catheter |
| FARAWAVE PFA Catheter | Active comparator | Participants with PsAF undergoing catheter ablation will undergo the ablation procedure with FARAWAVE catheter, and will be followed for up to 12 months post procedure. Eligible participants may enter an MRI subset and undergo MRI assessments at baseline and post-ablation procedure. Receives: Device: FARAWAVE Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Early Onset Primary Adverse Events (PAEs)
PAEs that 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.
Measured: Up to 7 days post-index procedure
Time to Occurrence of Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes
Time to occurrence of documented (symptomatic and asymptomatic) atrial tachyarrhythmia (atrial fibrillation [AF], atrial tachycardia [AT] or atrial flutter [AFL] of unknown origin) episodes based on electrocardiographic data (12-Lead Electrocardiogram (ECG) or greater than equal to (>=) 30 seconds on sponsor provided Cardiac Event Monitor (CEM) or Patch arrhythmia monitor) during the effectiveness evaluation period or 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 cardioversion (DCCV) procedure.
Measured: Day 61 and onward
Secondary outcomes (1)
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.
Measured: Baseline and at 6 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start2 Apr 2026
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 566 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
- NCT07523750
- Sponsor's protocol ID
- BWI202516
- Acronym
- PERSIGMA RCT
- Status last verified
- Nov 2026
- First submitted
- 6 Apr 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Comparison of Safety and Effectiveness of a VARIPULSE™ PFA Catheter to FARAWAVE™ PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07523750
- Acronym / sponsor ID
- PERSIGMA RCT / BWI202516
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 566 participants (estimated)
- Lead sponsor
- Biosense Webster, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 13 Apr 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 purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VARIPULSE Pulsed Field Ablation (PFA) Catheter | Experimental | Device: VARIPULSE CatheterParticipants with persistent atrial fibrillation (PsAF) undergoing catheter ablation will undergo the ablation procedure with VARIPULSE catheter, and will be followed for up to 12 months post procedure. Eligible participants may enter an magnetic resonance imaging (MRI) subset and undergo MRI assessments at baseline and post-ablation procedure. |
| FARAWAVE PFA Catheter | Active comparator | Device: FARAWAVE CatheterParticipants with PsAF undergoing catheter ablation will undergo the ablation procedure with FARAWAVE catheter, and will be followed for up to 12 months post procedure. Eligible participants may enter an MRI subset and undergo MRI assessments at baseline and post-ablation procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant has been diagnosed with symptomatic persistent atrial fibrillation (PsAF), which is defined as continuous atrial fibrillation (AF) sustained beyond 7 days and less than 365 days in duration documented by: i. A physician's note documenting diagnosis of symptomatic PsAF as defined above and ii. Two electrocardiograms showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be greater than [>] 365 days prior to enrollment) or iii. A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days
- Participant is aged 18 - 80 years at the time of informed consent
- Participant is willing and capable of providing informed consent
- Participant is able and willing to comply with all pre-, post- and follow-up testing and requirements
Key exclusion criteria (31 listed)
- Participant has continuous AF > 365 days (longstanding persistent AF)
- Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, etc.)
- Participant has had previous surgical or catheter ablation for AF
- Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and the cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
- Participant has severe dilatation of the LA (LAD > 50 millimeters [mm]) of the antero-posterior diameter confirmed by imaging performed within 180 days prior to enrollment
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 |
|---|---|---|
| VARIPULSE CatheterPulsed Field Ablation using the VARIPULSE catheter. | Device | VARIPULSE Pulsed Field Ablation (PFA) Catheter |
| FARAWAVE CatheterPulsed field ablation using the FARAWAVE catheter. | Device | FARAWAVE PFA Catheter |
Primary outcome
Occurrence of Early Onset Primary Adverse Events (PAEs)
Time frame: Up to 7 days post-index procedure
PAEs that 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 to Occurrence of Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes
Time frame: Day 61 and onward
Time to occurrence of documented (symptomatic and asymptomatic) atrial tachyarrhythmia (atrial fibrillation [AF], atrial tachycardia [AT] or atrial flutter [AFL] of unknown origin) episodes based on electrocardiographic data (12-Lead Electrocardiogram (ECG) or greater than equal to (>=) 30 seconds on sponsor provided Cardiac Event Monitor (CEM) or Patch arrhythmia monitor) during the effectiveness evaluation period or 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 cardioversion (DCCV) procedure.
1 secondary outcome
Change From Baseline in Quality of life, As Measured by the Total Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score
Time frame: Baseline and at 6 months post 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
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
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Atrial Fibrillation (AF)
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.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VARIPULSE Catheter and FARAWAVE Catheter in people with Atrial Fibrillation, run by Biosense Webster, Inc. at 20 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 31 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 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 20 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 Jesal Parekh (1 858 2108727, jparekh@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Early Onset Primary Adverse Events (PAEs) (time frame: Up to 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 3 Nov 2026.