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

NCT07845682 | Not Yet Recruiting FDA Device

• 1 other identifier: BWI202507
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 91 up to Day 365 post index procedure

• 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.

  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

  Baseline, At 12 months post procedure

Study Arms (1)

Radiofrequency/Pulsed Field Ablation

EXPERIMENTAL

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

Radiofrequency/Pulsed Field Ablation DEVICE

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

Radiofrequency/Pulsed Field Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Biosense Webster, Inc. Clinical Trial

  Biosense Webster, Inc.

  STUDY DIRECTOR

Central Study Contacts

Yun Bai

CONTACT

+86 15810492554; ybai8@its.jnj.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start: September 24, 2026
• Primary Completion (Estimated): April 17, 2028
• Study Completion (Estimated): April 17, 2028
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share