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Not yet recruitingNCT07845682DualSmartUpdated Sep 29, 2026

A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With TRUPULSE™ Generator in Persistent Atrial Fibrillation

An interventional study of Radiofrequency/Pulsed Field Ablation in Atrial Fibrillation, sponsored by Biosense Webster, Inc.. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Biosense Webster, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Atrial Fibrillation

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03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Radiofrequency/Pulsed Field Ablation

    Participants with persistent atrial fibrillation (PsAF) will undergo catheter ablation using the Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter in combination with the TRUPULSE™ generator according to the study procedural workflow.

    Device: Radiofrequency/Pulsed Field Ablation

Interventions

  • DeviceRadiofrequency/Pulsed Field Ablation

    Radiofrequency and pulsed field ablation by Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter with the TRUPULSE™ generator will be used.

05

What researchers measure

Primary outcomes

  1. Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes

    Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (that is, atrial fibrillation or atrial tachycardia or atrial flutter \[AF, AT or AFL\] of unknown origin) episodes based on electrocardiographic data and freedom from acute procedural failure, repeat ablation failure, non-study device failure, antiarrhythmic drug (AAD) failure, continuous AF/AT/AFL of unknown origin, and any direct current (DC) cardioversion procedure will be reported.

    Time frame: Day 91 up to Day 365 post index procedure

  2. Occurrence of Early Onset Primary Adverse Event (PAE)

    PAEs include the following Adverse Events (AEs): esophageal perforating complications (Atrio-esophageal fistula occuring up to 90 days post ablation procedure); phrenic nerve paralysis; cardiac Tamponade, perforation (occuring up to 30 days post ablation procedure); pulmonary vein stenosis (anytime during the 12 month follow up period); device or procedure related death (anytime during or after the ablation procedure); stroke/CVA; major vascular access complication/bleeding; thromboembolism; myocardial infarction; transient ischemic attack (TIA); pericarditis; heart block; pulmonary Edema (Respiratory Insufficiency); and vagal Nerve Injury/gastroparesis.

    Time frame: Within 7 days post index procedure

Secondary outcomes

  1. Change From Baseline in Quality of life, As Measured by the Total Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score at 12 Months Post Procedure

    The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 20 to 140. A score of 140 represents extreme distress (or extreme limitation, dissatisfaction or difficulty), while a score of 20 corresponds to no disability (or responding "not at all" limited, difficult or extreme satisfaction).

    Time frame: Baseline, At 12 months post procedure

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Yes — The data sharing policy of Johnson \& Johnson MedTech is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07845682
Lead sponsor
Biosense Webster, Inc.
Responsible party
Sponsor
First posted
Sep 29, 2026
Start date
Sep 24, 2026 (estimated)
Primary completion
Apr 17, 2028 (estimated)
Completion
Apr 17, 2028 (estimated)
Last update
Sep 29, 2026

Study contacts

Yun Bai
Contact
ybai8@its.jnj.com
+86 15810492554
Biosense Webster, Inc. Clinical Trial
study director · Biosense Webster, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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