A Study of the THERMOCOOL SMARTTOUCH Surround Flow (SF) Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic PAFOUS

Last updated: April 24, 2025
Sponsor: Biosense Webster, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Atrial Fibrillation

Chest Pain

Cardiac Disease

Treatment

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

Clinical Study ID

NCT06272981
BWI202308
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria::

  • Diagnosed with Symptomatic PAF (Physician's note indicating recurrentself-terminating AF). At least one (1) electrocardiographically documented AFepisode within twelve (12) months prior to enrollment. Electrocardiographicdocumentation may include, but is not limited to, electrocardiogram (ECG), Holtermonitor, or other electrocardiographical devices accepted by investigators

  • Failed at least one (1) Class I or Class III Antiarrhythmic Drug (AAD) as evidencedby recurrent symptomatic AF or has intolerable side effects or is contraindicated tothe Class I or Class III AAD

  • Able and willing to comply with all pre-procedure, post-procedure, and follow-uptesting and visit requirements

  • Willing and capable of providing consent

Exclusion

Exclusion Criteria:

  • AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiaccause (e.g., untreated documented obstructive sleep apnea and acute alcoholtoxicity)

  • Previous LA ablation or surgery

  • Patients known to require ablation outside the PV region (atrioventricular reentranttachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, atrialflutter of unknown origin, ventricular tachycardia and Wolff-Parkinson-White)

  • Previously diagnosed with persistent AF (> 7 days in duration)

  • Severe dilatation of the LA (documented LAD >50mm antero-posterior diameter onimaging within 6 months prior to enrollment

  • Documented left atrium (LA) thrombus within 48 hours prior to the index procedure byTransesophageal Echocardiography (TEE), or by Intracardiac Echocardiography (ICE)prior to transeptal puncture during procedure

  • Documented severely compromised LVEF (LVEF <40%) by imaging within 6 months prior toenrollment

  • Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV

  • History of blood clotting, bleeding abnormalities or contraindication toanticoagulation (heparin, warfarin, or dabigatran)

  • History of a documented thromboembolic event (including TIA) within the past 12months, or history of a documented left atrial appendage (LAA) thrombus

  • History of a documented symptomatic lacunar infarction within the past 12 months

  • Previous PCI/MI within the past 2 months

  • Coronary Artery Bypass Grafting (CABG) surgery within past 6 months

  • Valvular surgery, cardiac surgery (e.g., ventriculotomy, atriotomy) or valvularcardiac (surgical or percutaneous) procedure

  • Unstable angina pectoris within the past 6 months

  • Anticipated cardiac transplantation, cardiac surgery or other major surgery withinthe next 12 months

  • Significant pulmonary disease (e.g., restrictive pulmonary disease, constrictive orchronic obstructive pulmonary disease) or any other disease or malfunction of thelungs or respiratory system that produces severe chronic symptoms

  • Known significant PV anomaly that in the opinion of the investigator would precludeenrollment in this study

  • Has known pulmonary vein stenosis

  • Pre-existing hemi diaphragmatic paralysis

  • Acute illness, active systemic infection or sepsis

  • Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch orother abnormality that precludes catheter introduction or manipulation

  • Severe mitral regurgitation (Regurgitant volume 60 mL/beat, Regurgitant fraction 50%, and/or Effective regurgitant orifice area 0.40cm^2)

  • Presence of implanted pacemaker, Implantable Cardioverter-Defibrillator (ICD),recently implanted (within 6 months) LAAO device or other implanted metal cardiacdevice within the cardiac space that may interfere with the energy field createdduring the ablation procedure.

  • Presence of a condition that precludes vascular access (such as IVC filter)

  • Significant congenital anomaly or a medical problem that in the opinion of theinvestigator would preclude enrollment in this study

  • Categorized as vulnerable population and requires special treatment with respect tosafeguards of well-being

  • 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 childbearing age and plan on becoming pregnant during thecourse of the clinical investigation

  • Life expectancy less than 12 months

  • History of massive hemorrhage within the past 6 months

  • Presenting contra-indications for the devices

Study Design

Total Participants: 135
Treatment Group(s): 1
Primary Treatment: Pulsed Field (PF) /Radiofrequency (RF) Catheter ablation
Phase:
Study Start date:
February 28, 2024
Estimated Completion Date:
August 29, 2025

Connect with a study center

  • Royal Prince Alfred Hospital

    Camperdown, 2050
    Australia

    Site Not Available

  • Canberra Heart Rhythm

    Garran, 2605
    Australia

    Site Not Available

  • John Hunter Hospital

    New Lambton Heights, 2305
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, 2145
    Australia

    Site Not Available

  • Southlake Regional Health Centre

    Newmarket, Ontario L3Y 2P9
    Canada

    Site Not Available

  • University of Ottawa Heart Institute

    Ottawa, Ontario K1Y 4W7
    Canada

    Site Not Available

  • McGill University Health Centre

    Montreal, Quebec H3G 1A4
    Canada

    Site Not Available

  • Montreal Heart Institute

    Montreal, Quebec H1T 1C8
    Canada

    Site Not Available

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