protocolSection identificationModule nctId: NCT06272981, orgStudyIdInfo id: BWI202308, briefTitle: A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAFOUS, acronym: PulseSmart, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2025-08-29, completionDateStruct date: 2025-08-29, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Biosense Webster, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to demonstrate safety and effectiveness of the Biosense Webster (BWI) ablation system (THERMOCOOL SMARTTOUCH surround flow \[STSF\] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF), an irregular heart rate that causing abnormal blood flow., conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 135, type: ESTIMATED, armsInterventionsModule interventions name: Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation, outcomesModule primaryOutcomes measure: Number of Participants with Primary Adverse Events (PAEs), primaryOutcomes measure: Rate of Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation (AF), Atrial Tachycardia (AT) or Atrial Flutter (AFL) of Unknown Origin) within 91-365 Days Post Index Procedure, secondaryOutcomes measure: Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Prince Alfred Hospital, status: NOT_YET_RECRUITING, city: Camperdown, zip: 2050, country: Australia, geoPoint lat: -33.88965, lon: 151.17642, locations facility: Canberra Heart Rhythm, status: RECRUITING, city: Garran, zip: 2605, country: Australia, geoPoint lat: -35.34206, lon: 149.10846, locations facility: John Hunter Hospital, status: WITHDRAWN, city: New Lambton Heights, zip: 2305, country: Australia, geoPoint lat: -32.92466, lon: 151.69364, locations facility: Westmead Hospital, status: RECRUITING, city: Westmead, zip: 2145, country: Australia, geoPoint lat: -33.80383, lon: 150.98768, locations facility: Southlake Regional Health Centre, status: NOT_YET_RECRUITING, city: Newmarket, state: Ontario, zip: L3Y 2P9, country: Canada, geoPoint lat: 44.05011, lon: -79.46631, locations facility: University of Ottawa Heart Institute, status: NOT_YET_RECRUITING, city: Ottawa, state: Ontario, zip: K1Y 4W7, country: Canada, geoPoint lat: 45.41117, lon: -75.69812, locations facility: Montreal Heart Institute, status: NOT_YET_RECRUITING, city: Montreal, state: Quebec, zip: H1T 1C8, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: McGill University Health Centre, status: NOT_YET_RECRUITING, city: Montreal, state: Quebec, zip: H3G 1A4, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False