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Study of VARIPULSE and FARAWAVE Catheters for Persistent Atrial Fibrillation

This study is looking at how safe and effective a new device, the VARIPULSE catheter, is for treating symptomatic persistent atrial fibrillation (PsAF). PsAF is a continuous irregular heartbeat that lasts over 7 days. The VARIPULSE catheter uses pulsed field ablation (PFA), a procedure that uses controlled electrical pulses to correct heart rhythm. Researchers will compare VARIPULSE to the FARAWAVE PFA catheter, which is already approved by the FDA. You may be able to join if you are between 18 and 80 years old and have been diagnosed with symptomatic persistent atrial fibrillation lasting between 7 days and one year. The study will measure how often serious problems occur within 7 days after the procedure, and how well the treatment prevents irregular heartbeats from day 61 onward. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 466 participants. It compares two different pulsed field ablation catheters.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events up to 7 days after the procedure, and for freedom from irregular heartbeats from day 61 onward.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07523750

A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation

Recruiting
NAAges 18–80InterventionalTreatment
Biosense Webster, Inc.
~566 participants
Updated 2026-09-15 on ClinicalTrials.gov
What's tested:VARIPULSE CatheterFARAWAVE Catheter

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of Early Onset Primary Adverse Events (PAEs)
Measured over Up to 7 days post-index procedure
+1 more outcome measured

Conditions

Atrial Fibrillation

Explore related trials

Atrial Fibrillation

NCT07523750

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arrhythmia Research Group

    Jonesboro, Arkansasno site contact published

    Recruiting

  • Baylor Research Institute

    Plano, Texasno site contact published

    Recruiting

  • Community Memorial Hospital

    Ventura, Californiano site contact published

    Recruiting

  • Intermountain Medical Center

    Murray, Utahno site contact published

    Recruiting

  • Lenox Hill Hospital

    New York, New Yorkno site contact published

    Recruiting

  • Montefiore Medical Center

    The Bronx, New Yorkno site contact published

    Recruiting

  • NCH Healthcare

    Naples, Floridano site contact published

    Recruiting

  • OC Medical Center

    Fountain Valley, Californiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Biosense Webster, Inc. Clinical Trial · STUDY_DIRECTOR · Biosense Webster, Inc.

Who to contact

Jesal Parekh
[email protected]
1 858 2108727
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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
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
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

What this trial measures

  • Occurrence of Early Onset Primary Adverse Events (PAEs)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 EpisodesDay 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.