VARIPULSE catheter setup for persistent atrial fibrillation during vein/superior vena cava isolation
Official title: Assessment of the Safety and Effectiveness of the VARIPULSE™ Catheter System in the Treatment of Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein (With or Without Posterior Wall Isolation) and Superior Vena Cava Isolation: A Randomized Controlled Trial
Run by Biosense Webster, Inc. · NCT07527299 · Data updated 2026-11-12
This study tests the VARIPULSE catheter system in people with persistent atrial fibrillation who are undergoing catheter ablation to isolate heart veins, with or without adding a left atrial appendage occlusion in some cases.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 1070 (estimated) |
| Sponsor | Biosense Webster, Inc. Industry-sponsored |
| Locations | 13 sites (Birmingham, Alabama and 12 other locations) |
| Status | Recruiting |
| Started | August 26, 2026 |
| Main results expected | November 30, 2028 |
| Study ends | August 24, 2031 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07527299 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 80 with symptomatic persistent atrial fibrillation undergoing ablation (PVI/SVCI, with or without PWI), with or without planned LAAO when clinically indicated.
✕Probably not a fit
Patients with non-persistent or paroxysmal AF, or those not undergoing ablation with VARIPULSE involvement, may not experience benefit from this catheter system.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates the safety and long-term performance of the VARIPULSE catheter system in adults with symptomatic persistent atrial fibrillation undergoing catheter ablation that targets pulmonary vein and superior vena cava isolation, with optional posterior wall isolation. A subset may also receive a left atrial appendage occlusion procedure to reduce stroke risk. Participants will be followed to assess safety outcomes and the durability of the ablation approach over time. The study is conducted at three U.S. sites and is sponsored by Biosense Webster, Inc. Outcomes will inform the safety profile and potential benefits of integrating VARIPULSE with standard ablation techniques.
Why it matters
Potential benefit: If successful, participants may experience safer ablation procedures and potentially better long-term rhythm control for persistent atrial fibrillation.
How similar studies have gone: Prior ablation studies using advanced catheters suggest safety and effectiveness in AF procedures, but results with VARIPULSE in combination with LAAO are novel and require further validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * 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 Left atrial appendage occlusion (LAAO) concomitant subset: \- Participant is clinically indicated for a LAAO procedure Exclusion criteria: * 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 LAAO concomitant subset: * 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)
Where it's running
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Grandview Medical Center
Birmingham, Alabama, United States Recruiting -
Pima Heart and Vascular
Tucson, Arizona, United States Recruiting -
Arrhythmia Research Group
Jonesboro, Arkansas, United States Recruiting -
Pacific Heart Institute Cedars Sinai Medical Center
Santa Monica, California, United States Recruiting -
Aurora Denver Cardiology Associates
Aurora, Colorado, United States Recruiting -
Hartford Hospital
Hartford, Connecticut, United States Recruiting
Show 7 more locations
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JFK Medical Center
Atlantis, Florida, United States Recruiting -
Saint Elizabeth Medical Center
Edgewood, Kentucky, United States Recruiting -
Munson Medical Center
Traverse City, Michigan, United States Recruiting -
Albert Einstein College Of Medicine - Montefiore Medical Center
The Bronx, New York, United States Recruiting -
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States Recruiting -
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States Recruiting -
Mercy Hospital
Janesville, Wisconsin, United States Recruiting
Study contacts
- Study coordinator: Narvelle Delabruere
- Email: NDelabru@its.jnj.com
- Phone: 949-933-1710
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.