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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Biosense Webster, Inc. • ClinicalTrials.gov ID: NCT07429214

Registry updated: 2026-09-25
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Description

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).

Interventions

  • Pulsed Field Ablation System (Device)
    Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator along with VARIPULSE pro software will be used.

Eligibility criteria

Inclusion criteria: * 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 Exclusion criteria: * 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 * Significant congenital anomaly or medical problems that in the opinion of the investigator would preclude enrollment in this study * Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation * Current enrollment in an investigational study evaluating another device, biologic, or drug * Presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (IFU) * Categorized as vulnerable population and requiring special treatment with respect to safeguards of well-being * Life expectancy less than 12 months * Contraindication for MRI such as use of contrast agents due to advanced renal disease, claustrophobia, implantable pacemakers, implantable cardioverter/defibrillators (ICDs),etc. (at principal investigator \[PI\] discretion) * Presence of iron-containing metal fragments in the body * Unresolved pre-existing neurological deficit

Conditions

Atrial Fibrillation

Locations

  • AZORG campus Aalst Moorselbaan — Aalst, Belgium
  • A.Z. Sint Jan — Bruges, Belgium
  • Aarhus University Hospital — Aarhus N, Denmark
  • University Hospital of the Ruhr-University of Bochum — Bad Oeynhausen, Germany
  • IRCCS Policlinico San Donato — San Donato Milanese, Italy
  • Vilnius University Hospital Santaros Clinics — Vilnius, Lithuania
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record