A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE PRO Software in Participants With PsAF

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation

In brief

The main purpose of this study is to investigate the 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 persistent atrial fibrillation (PsAF; irregular, rapid heart rhythm that lasts over 7 days and doesn't stop on its own)

Key facts

Study ID: NCT07428564
Run by: Biosense Webster, Inc.
People needed: 50
Starts: 2026-05-19
Expected to finish: 2026-12-30
Last updated by the study team: 2026-07-07

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)
Selected to undergo an ablation procedure for management of their arrhythmia by pulmonary vein isolation (PVI) +
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 millimeter [mm] antero-posterior diameter in case of transthoracic echocardiography [TTE])
Severely compromised left ventricular ejection fraction (LVEF less than [<] 40%)
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)
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 squared [kg/m\^2]), renal insufficiency (with an estimated creatinine clearance < 30 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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