VARIPULSE pulsed-field catheter with TRUPULSE generator and Pro software for atrial fibrillation ablation

Workflow Study of the VARIPULSE™ Catheter With the TRUPULSE™ Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF) or Persistent Atrial Fibrillation (PsAF) With the New VARIPULSE™ Pro Software

This trial will try a pulsed-field ablation system (VARIPULSE catheter with TRUPULSE generator and VARIPULSE Pro software) to treat people aged 18–75 with paroxysmal or persistent atrial fibrillation undergoing pulmonary vein isolation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Biosense Webster, Inc. (Industry-sponsored)
• Locations: 10 sites (Aalst and 9 other locations)
• Trial ID: NCT07429214 on ClinicalTrials.gov

What this trial studies

This interventional study uses the VARIPULSE pulsed-field ablation catheter and TRUPULSE generator with the new VARIPULSE Pro software to perform pulmonary vein isolation (PVI), with optional cavotricuspid isthmus ablation, in participants with paroxysmal or persistent atrial fibrillation. Eligible adults are 18–75, symptomatic, have failed at least one antiarrhythmic drug, and have not had prior AF ablation or recent cardiac surgery. The trial focuses on clinical workflow, procedural performance, and peri-procedural safety when using the device and software during routine ablation procedures. Participating centers will collect procedural details and follow-up data to document outcomes and recovery.

Who should consider this trial

Good fit: Adults 18–75 with symptomatic paroxysmal or persistent AF who are planned for PVI (with or without CTI ablation), have failed at least one antiarrhythmic drug, and can consent and attend follow-up visits.

Not a fit: People with continuous AF longer than 12 months, prior surgical or catheter AF ablation, recent cardiac surgery, or other exclusion criteria are unlikely to be eligible or to receive benefit from this workflow-focused study.

Why it matters

Potential benefit: If successful, the system could make pulmonary vein isolation faster and more precise while reducing damage to surrounding tissue, potentially improving safety and symptom control.

How similar studies have performed: Other pulsed-field ablation studies have shown promising safety and effective pulmonary vein isolation, but use of this specific VARIPULSE system with Pro software is newer and is being tested for real-world workflow and use.

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 etc. (at principal investigator \[PI\] discretion)
* Presence of iron-containing metal fragments in the body
* Unresolved pre-existing neurological deficit

Where this trial is running

Aalst and 9 other locations

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

Study contacts

• Study coordinator: Nathalie Macours

Conditions Atrial Fibrillation