A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation

In brief

The main purpose of this clinical study is to investigate the effectiveness workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE™ Catheter and TRUPULSE™ Generator) when used for cardiac ablation with the new VARIPULSE™ Pro software in participants with paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days up to 1year and doesn't stop on its own).

Key facts

Study ID

NCT07429214

Run by

Biosense Webster, Inc.

People needed

50

Starts

2026-03-23

Expected to finish

2026-12-30

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with symptomatic persistent atrial fibrillation (PsAF) or paroxysmal atrial fibrillation (PAF)
• Selected to undergo an ablation procedure for management of their arrhythmia by pulmonary vein isolation (PVI) only or PVI only with cavotricuspid isthmus (CTI) dependent atrial flutter ablation
• Failed at least one antiarrhythmic drug (AAD; class I to IV) as evidenced by recurrent symptomatic atrial fibrillation (AF), or intolerable or contraindicated to the AAD
• Age 18-75 years
• Willing and capable of providing consent
• Able and willing to comply with all pre-, post- and follow-up testing and requirements

You may not qualify if…

• Continuous AF greater than (>) 12 months (1-Year) (Longstanding Persistent AF)
• Previous surgical or catheter ablation for atrial fibrillation
• Any cardiac surgery within the past 2 months (60 days prior to consent date) (includes percutaneous coronary intervention [PCI])
• Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (for example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure
• Any carotid stenting or endarterectomy
• Presence of left atrium (LA) thrombus
• Severe dilatation of the LA (left atrial diameter [LAD] >50 millimeters [mm] antero-posterior diameter in case of transthoracic echocardiography [TTE])
• Severely compromised left ventricular ejection fraction (LVEF less than [<] 40 percent [%])
• Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study
• Prior diagnosis of pulmonary vein stenosis
• Pre-existing hemi diaphragmatic paralysis
• History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
• Myocardial infarction (MI) within the past 2 months (60 days prior to consent date)
• Documented thromboembolic event (including transient ischemic attack [TIA]) within the past 6 months [180 days prior to consent date])
• Rheumatic Heart Disease
• Uncontrolled heart failure or New York heart association (NYHA) function class III or IV
• Severe mitral regurgitation
• Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
• Unstable angina pectoris within the past 6 months prior to consent date
• Acute illness or active systemic infection or sepsis
• Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity [Body Mass Index >40 kilogram per meter square {kg/m\^2}], renal insufficiency (with an estimated creatinine clearance < 30 milliliters per minute {mL/min}/1.73 m\^2)
• Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch, prosthetic valve or other abnormality that precludes catheter introduction or manipulation
• Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter
• Presence of any other condition that precludes appropriate vascular access (such as inferior vena cava [IVC] filter)
• Significant pulmonary disease, (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease [COPD]) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms

Where it is running

• Aarhus University Hospital — Aarhus N, Denmark (enrolling)
• A.Z. Sint Jan — Bruges, Belgium (enrolling)
• Vilnius University Hospital Santaros Clinics — Vilnius, Lithuania (enrolling)
• AZORG campus Aalst Moorselbaan — Aalst, Belgium (enrolling)
• Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata' — Roma, Italy
• IRCCS Policlinico San Donato — San Donato Milanese, Italy
• Erasmus MC — Rotterdam, Netherlands
• Hospices Civils de Lyon HCL — Bron, France
• Institut Medico chirurgical Montsouris — Paris, France
• University Hospital of the Ruhr-University of Bochum — Bad Oeynhausen, Germany

Full record on ClinicalTrials.gov

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