A Study For Treatment Of Paroxysmal Atrial Fibrillation (PAF) With The THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator

Last updated: June 16, 2025
Sponsor: Biosense Webster, Inc.
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Arrhythmia

Dysrhythmia

Treatment

Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation

Clinical Study ID

NCT05752487
BWI202202
BWI202202
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to demonstrate safety and effectiveness of the ablation system (THERMOCOOL SMARTTOUCH SF [STSF] catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) defined as atrialfibrillation (AF) that terminates spontaneously or with intervention within 7 daysof onset. This PAF is considered to be symptomatic if symptoms related to AF areexperienced by the participant

  • Selected for AF ablation procedure by pulmonary vein isolation (PVI)

  • Failed at least one antiarrhythmic drug (AAD) (class I to IV) as evidenced byrecurrent symptomatic AF, or intolerable or contraindicated to the AAD

  • Willing and capable of providing consent

  • Able and willing to comply with all pre-, post- and follow-up testing andrequirements.

Exclusion

Exclusion Criteria:

  • Previously known AF secondary to electrolyte imbalance, thyroid disease, orreversible or non-cardiac cause (example, documented obstructive sleep apnea, acutealcohol toxicity, morbid obesity {Body Mass Index greater than [>] 40 kilograms permeter square [kg/m²]}, renal insufficiency (with an estimated creatinine clearanceless than [<] 30 milliliters [mL]/ minute [min]/1.73 meter square [m2] )

  • Previous left atrium (LA) ablation or surgery

  • Patients known to require ablation outside the pulmonary vein (PV) region (example,atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia,atrial tachycardia, ventricular tachycardia and wolff-parkinson-white)

  • Previously diagnosed with persistent AF [greater than (>) 7 days in duration]

  • Severe dilatation of the left atrium (LA) (Left anterior descending artery [LAD] >50mm antero-posterior diameter in case of Transthoracic Echocardiography [TTE])

Study Design

Total Participants: 149
Treatment Group(s): 1
Primary Treatment: Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
Phase:
Study Start date:
February 27, 2023
Estimated Completion Date:
June 17, 2024

Connect with a study center

  • Medical University Graz

    Graz, 8036
    Austria

    Site Not Available

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, 4020
    Austria

    Site Not Available

  • O L V Ziekenhuis

    Aalst, 9300
    Belgium

    Site Not Available

  • O.L.V. Ziekenhuis

    Aalst, 9300
    Belgium

    Site Not Available

  • AZ Sint-Jan

    Brugge, 8000
    Belgium

    Site Not Available

  • Ziekenhuis Oost-Limburg

    Genk, 3600
    Belgium

    Site Not Available

  • Jessa Ziekenhuis

    Hasselt, 3500
    Belgium

    Site Not Available

  • Aarhus University Hospital

    Aarhus, 8200
    Denmark

    Site Not Available

  • Gentofte Hospital

    Hellerup, 2900
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense C, 5000
    Denmark

    Site Not Available

  • Vilnius University Hospital Santaros Clinics

    Vilnius, 08661
    Lithuania

    Site Not Available

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