Back to search results

Study of VARIPULSE Catheter for Persistent Atrial Fibrillation

This study is looking at the VARIPULSE Catheter System to treat persistent atrial fibrillation (PsAF), a type of irregular heartbeat that lasts longer than 7 days. Researchers want to see how safe this system is when used during a catheter ablation procedure, which treats heart rhythm problems by isolating specific areas of the heart (pulmonary vein and superior vena cava). The study also looks at its safety when combined with another procedure called left atrial appendage occlusion (LAAO), which helps reduce stroke risk. They will also assess how well the VARIPULSE system works over time to keep your heart rhythm steady. You may be able to join if you are 18 to 80 years old and have been diagnosed with symptomatic persistent atrial fibrillation lasting between 7 days and 365 days. The study aims to enroll 920 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 920 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety up to about 7 days after the procedure, and for how well the treatment works from Day 61 up to Day 180.

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

NCT07527299

A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation

Recruiting
NAAges 18–80InterventionalTreatment
Biosense Webster, Inc.
~1,070 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:VARIPULSE Catheter SystemLAAO Device

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Early Onset Primary Adverse Events (PAEs)
Measured over Up to approximately 7 days post-procedure
+1 more outcome measured

Conditions

Atrial Fibrillation

Explore related trials

Atrial Fibrillation

NCT07527299

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Albert Einstein College Of Medicine - Montefiore Medical Center

    The Bronx, New Yorkno site contact published

    Recruiting

  • Arrhythmia Research Group

    Jonesboro, Arkansasno site contact published

    Recruiting

  • Pima Heart and Vascular

    Tucson, Arizonano 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

Narvelle Delabruere
[email protected]
949-933-1710
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
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 in duration 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 (ECGs) 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 requirement

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 LA (left atrial) anteroposterior \>= 55 millimeter (mm) (by magnetic resonance imaging \[MRI\], computed tomography \[CT\], or transthoracic echocardiogram \[TTE\]), or if LA diameter is not available, non-index volume \>100 milliliter (mL) confirmed within 365 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 (left ventricle ejection fraction \[LVEF\] less than \[\<\] 40 percent \[%\]) 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 functional classification
Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)
Participant has had a thromboembolic event (including transient ischemic attack \[TIA\]) within the past 180 days prior to enrollment
Participant has had a percutaneous coronary intervention or acute myocardial infarction (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 (that is, 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%, and/or Effective regurgitant orifice area \>= 0.40 square centimeter \[cm\^2\])
Participants with an implanted metal cardiac device that may interfere with the pulsed field energy field are excluded, including but not limited to: -MitraClip, -LAAO devices (for example, WATCHMAN, Amulet), -Double-coiled implantable cardioverter-defibrillators (ICDs). This exclusion does not apply to participants with any of the following devices: -Coronary stents, -Implanted pacemakers, -Single-coiled ICDs, -Implantable loop recorders (ILRs)
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 of less than 365 days
Participant has contraindications for the devices used in the study, as indicated in the respective instructions for use (IFUs)
Participant has contraindications for the ablation of the SVC
Participant is contraindicated for a LAAO procedure per the instructions of use of the planned LAAO device
Participant with prior LAAO procedure (attempted or successful)

What this trial measures

  • Number of Participants with Early Onset Primary Adverse Events (PAEs)Up to approximately 7 days post-procedure

    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.

  • Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia EpisodesDay 61 up to Day 180

    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.