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
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).
Exclusion criteria:
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
Radiofrequency and pulsed field ablation by Dual Energy THERMOCOOL SMARTTOUCH™ SF (DE STSF) catheter with the TRUPULSE™ generator will be used.
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
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
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
No study locations are listed for this record.
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.
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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Biosense Webster, Inc.