Testing a Catheter Ablation System for Long-Lasting Atrial Fibrillation

Trial details

Who runs it

Biosense Webster, Inc.

Trial code

NCT07845682

Record updated

4 November 2026

Original description

This purpose of this study is to understand how safe Biosense Webster Pulsed Field (PF)/Radiofrequency (RF) ablation system is and how well it works over 12 months in participants with persistent atrial fibrillation (PsAF; abnormal heart signals that cause irregular heartbeats).Read full original descriptionShow less

A Prospective, Multicenter, Single Arm With Performance Goal Study to Evaluate Safety and Effectiveness of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator in Persistent Atrial Fibrillation (PsAF)

This purpose of this study is to understand how safe Biosense Webster Pulsed Field (PF)/Radiofrequency (RF) ablation system is and how well it works over 12 months in participants with persistent atrial fibrillation (PsAF; abnormal heart signals that cause irregular heartbeats).

Inclusion: Documented symptomatic persistent atrial fibrillation (AF), which is defined as continuous AF that sustains beyond 7 days and less than 1 year and is documented by the following: Physician's note indicating continuous AF greater than or equal to (>=) 7 days but no more than 1 year; AND 1) Two electrocardiograms (from any forms of rhythm monitoring) showing continuous AF, with electrocardiogram taken at least 7 days apart (electrograms cannot >12 months prior to enrollment) OR 2) At least 24-hour Holter/ telemetry strip within 12 months prior to enrollment showing continuous AF; Failed at least one (1) antiarrhythmic drug (AAD) (Class I or Class III) as evidenced by recurrent symptomatic AF, intolerable to the AAD; Age 18-80 years; Willing and capable of providing consent; Able and willing to comply with all pre-, post- and follow-up testing and requirement.

Exclusion: Documented severe dilatation of the left atrium (LA) (LAD >50 millimetre [mm]) antero-posterior diameter on imaging within 6 months prior to procedure; Documented LA thrombus by imaging within 48 hours of the procedure or by intracardiac echocardiography (ICE) prior to transeptal puncture during procedure; Concomitant other arrhythmia, including: atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial flutter of unknown origin, ventricular tachycardia and Wolff-Parkinson-Whiteexcept cavotricuspid isthmus (CTI) lines for the ablation of typical right atrial flutter; Previous LA ablation or surgery; Coronary artery bypass grafting (CABG) surgery within the past 6 months (180 days); Significant congenital anomaly (for example, american society for dermatologic surgery [ASDs]) including treated or medical problem that in the opinion of the investigator would preclude enrollment in this study; Prior diagnosis of pulmonary vein stenosis; Current enrollment in an investigational study evaluating another device or drug; AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, etcetera); Severe mitral regurgitation or insufficiency, or the report claims: Regurgitant volume >=60 millilitre (mL)/beat, Regurgitant fraction >=50%, and/or effective regurgitant orifice area >=0.40 square centimetre (cm\^2); Moderate-severe, severe tricuspid valve regurgitation or insufficiency; Valvular cardiac surgical/percutaneous procedure (that is, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve); Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months; Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV; History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, etcetera); History of a documented symptomatic lacunar infarction within the past 12 months; Participants with percutaneous coronary intervention or acute myocardial infarction within 3 months; Unstable angina within the past 6 months; 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; Presence of a condition that precludes vascular access; Acute illness, active systemic infection, or sepsis; Participant has an implanted metal cardiac device, including MitraClip and left atrial appendage occlusion (LAAO) devices (for example, WATCHMAN, Amulet, etcetera) (this exclusion does not include coronary stents, implanted pacemakers, implantable cardioverter-defibrillators [ICD] and implantable loop recorders [ILR]); History of massive haemorrhage within the past 6 months; Documented severely compromised left ventricular ejection fraction (LVEF) (LVEF less than [<] 40 percent [%]) by imaging within 6 months prior to procedure; Women who are pregnant (as evidenced by pregnancy test if pre- menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation; Documented thromboembolic event (including transient ischemic attack [TIA]) within the past 12 months; Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation; Pre-existing hemi diaphragmatic paralysis; Life expectancy less than 12 months; Those considered by the investigators as not suitable for participating in this clinical study.

ClinicalTrials.gov NCT07845682