Dual Energy ablation with SmartTouch SF catheter in persistent atrial fibrillation
Official title: 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)
Run by Biosense Webster, Inc. · NCT07845682 · Data updated 2026-11-12
This study tests a pulsed field and radiofrequency ablation system to treat persistent atrial fibrillation in adults who have not responded well to prior medications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Biosense Webster, Inc. Industry-sponsored |
| Locations | 4 sites (Beijing and 3 other locations) |
| Status | Recruiting |
| Started | October 14, 2026 |
| Main results expected | April 17, 2028 |
| Study ends | April 17, 2028 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07845682 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 80 with symptomatic persistent AF lasting 7 days to less than 1 year who have failed at least one antiarrhythmic drug and can consent and comply with follow-up.
✕Probably not a fit
Patients with AF due to electrolyte or thyroid disorders or other reversible causes may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates the safety and effectiveness of a biosense webster pulsed field/radiofrequency ablation system using the ThermoCool SmartTouch SF catheter with a TRUPULSE generator in adults with persistent atrial fibrillation. Participants must have symptomatic AF lasting 7 days to less than a year and have failed at least one antiarrhythmic drug. The procedure, follow-up testing, and 12-month monitoring are designed to assess rhythm outcomes and device-related safety. Enrollment is limited to multiple centers in China and is sponsored by Biosense Webster, Inc. No comparator group is described in the provided information.
Why it matters
Potential benefit: If successful, patients could experience reduced AF symptoms and lower risk of recurrent episodes over 12 months.
How similar studies have gone: Previous studies of pulsed field and radiofrequency ablation strategies have shown potential benefits in AF, but results can vary by technology and patient population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * 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 criteria: * AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, etcetera) * Documented severe dilatation of the left atrium (LA) (LAD \>50 millimetre \[mm\]) antero-posterior diameter on imaging within 6 months prior to procedure * Documented severely compromised left ventricular ejection fraction (LVEF) (LVEF less than \[\<\] 40 percent \[%\]) by imaging within 6 months prior to procedure * 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 * 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 * 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) * Documented thromboembolic event (including transient ischemic attack \[TIA\]) within the past 12 months * History of a documented symptomatic lacunar infarction within the past 12 months * Participants with percutaneous coronary intervention or acute myocardial infarction within 3 months * Coronary artery bypass grafting (CABG) surgery within the past 6 months (180 days) * 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 * 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 * Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation * Presence of a condition that precludes vascular access * Prior diagnosis of pulmonary vein stenosis * Pre-existing hemi diaphragmatic paralysis * 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 \[ILR\]) * Current enrollment in an investigational study evaluating another device or drug * 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 * Life expectancy less than 12 months * History of massive haemorrhage within the past 6 months * Those considered by the investigators as not suitable for participating in this clinical study
Where it's running
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Beijing Anzhen Hospital, Capital Medical University
Beijing, China Recruiting -
Qilu Hospital of Shandong University
Jinan, China Recruiting -
Jiangsu Province Hospital
Nanjing, China Recruiting -
Shanghai Chest Hospital
Shanghai, China Recruiting
Study contacts
- Study coordinator: Yun Bai
- Email: ybai8@its.jnj.com
- Phone: +86 15810492554
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.