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

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation

In brief

The purpose of this study is to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat heart rhythm disease). This includes isolation of pulmonary vein and superior vena cava (heart veins; pulmonary vein isolation \[PVI\] and superior vena cava isolation \[SVCI\]), with or without another technique called posterior wall isolation (PWI). Also, to assess how safe it is for participants who are having a catheter ablation procedure and at the same time receiving another procedure called left atrial appendage occlusion (LAAO; to reduce stroke risk). Additionally, to assess how well VARIPULSE catheter system works over a long period of time for treatment of PsAF in participants undergoing catheter ablation for PVI, SVCI and SVCI+PWI.

Key facts

Study ID

NCT07527299

Run by

Biosense Webster, Inc.

People needed

1070

Starts

2026-08-05

Expected to finish

2031-08-04

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pima Heart and Vascular — Tucson, Arizona, United States (enrolling)
• Arrhythmia Research Group — Jonesboro, Arkansas, United States (enrolling)
• Albert Einstein College Of Medicine - Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• Tucson Medical Center — Tucson, Arizona, United States
• Washington Regional Medical Center — Fayetteville, Arkansas, United States
• Marin General Hospital — Larkspur, California, United States
• Hoag Memorial Hospital — Newport, California, United States
• Pacific Heart Institute Cedars Sinai Medical Center — Santa Monica, California, United States
• Aurora Denver Cardiology Associates — Aurora, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• JFK Medical Center — Atlantis, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• The Kansas City Heart Rhythm Institute — Overland Park, Kansas, United States
• Saint Elizabeth Medical Center — Edgewood, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Lindner Clinical Trial Center/Christ Hospital — Cincinnati, Ohio, United States
• Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Houston Methodist Sugarland — Sugar Land, Texas, United States
• Mercy Hospital — Janesville, Wisconsin, United States
• Monash Health Victorian Heart Hospital — Clayton, Australia
• John Hunter Hospital — New Lambton Heights, Australia
• Grandview Medical Center — Birmingham, Alabama, United States
• Westmead Hospital — Westmead, Australia

Full record on ClinicalTrials.gov

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