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

Last updated: March 27, 2025
Sponsor: Biosense Webster, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Arrhythmia

Chest Pain

Dysrhythmia

Treatment

TRUPULSE Generator

THERMOCOOL STSF Bi- Directional Navigation Catheter

Clinical Study ID

NCT06144632
BWI202204
BWI202204
  • Ages 18-75
  • 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 paroxysmal atrial fibrillation (PAF) with (a) at leasttwo symptomatic atrial fibrillation (AF) episodes within last six months fromenrollment and (b) at least one AF episode electrocardiographically documented byelectrocardiogram (ECG); transtelephonic monitoring (TTM), Holter monitor, telemetrystrip or implanted device within 12 months prior to enrollment

  • Failed at least one antiarrhythmic drug (AAD) (Class I or Class III) as evidenced byrecurrent symptomatic AF, intolerable side effects to the AAD, or contraindicationto 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:

  • AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiaccause (for example, documented obstructive sleep apnea, acute alcohol toxicity,etcetera)

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

  • Previous left atrium (LA) ablation or surgery

  • Participants known to require ablation outside the pulmonary vein (PV) region (forexample, atrioventricular reentrant tachycardia, atrioventricular nodal reentrytachycardia, ventricular tachycardia, and Wolff-Parkinson-White), exceptcavotricuspid isthmus (CTI) lines for the ablation of typical right atrial flutter

  • Documented severe dilatation of the LA (left anterior descending artery [LAD] >50mm)antero-posterior diameter on imaging within 6 months prior to enrollment

  • Documented LA thrombus by imaging within 48 hours of the procedure

  • Documented severely compromised left ventricular ejection fraction (LVEF less than [<] 40 percent [%]) by imaging within 6 months prior to enrollment

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

  • History of blood clotting, bleeding abnormalities or contraindication toanticoagulation (heparin) except subjects with prior left atrial appendage closure

  • Documented thromboembolic event (including transient ischemic attack [TIA]) withinthe past 12 months

  • Participants with unstable angina, percutaneous coronary intervention or acutemyocardial infarction within 2 months

  • Coronary artery bypass grafting (CABG) surgery within the past 6 months (180 days)

  • Valvular cardiac surgical/percutaneous procedure (that is, ventriculotomy,atriotomy, valve repair or replacement and presence of a prosthetic valve)

  • Unstable angina within 6 months

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

  • Significant pulmonary disease (for example, restrictive pulmonary disease,constrictive or chronic obstructive pulmonary disease) or any other disease ormalfunction of the lungs or respiratory system that produces severe chronic symptoms

  • Significant congenital anomaly (for example, atrial septal defects [ASDs]) includingrepaired defects or medical problem that in the opinion of the investigator wouldpreclude enrollment in this study

  • Prior diagnosis of 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 greater than or equal to [>=] 60milli liter (mL)/beat, Regurgitant fraction >= 50%, and/or Effective regurgitantorifice area >= 0.40 cm^2)

  • Presence of implanted pacemaker, Implantable Cardioverter-Defibrillator (ICD),recently implanted (within 6 months) left atrial appendage occlusion (LAAO) deviceor other implanted metal cardiac device within cardiac space that may interfere withthe energy field created during the ablation procedure

  • Presence of a condition that precludes vascular access

  • 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 child-bearing age and plan on becoming pregnant during thecourse of the clinical investigation

  • Life expectancy less than 12 months

  • Presenting contra-indications for the devices used in the study, as indicated in therespective Instructions for Use (IFU)

Study Design

Total Participants: 237
Treatment Group(s): 2
Primary Treatment: TRUPULSE Generator
Phase:
Study Start date:
December 07, 2023
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Grandview Medical Center

    Birmingham, Alabama 35243
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Keck School of Medicine of USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • California Pacific Medical Center- Sutter Health

    San Francisco, California 94109
    United States

    Site Not Available

  • HCA Florida JFK Hospital

    Atlantis, Florida 33462
    United States

    Site Not Available

  • Ascension St. Vincent's

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • HCA Florida Mercy Hospital

    Miami, Florida 33133
    United States

    Site Not Available

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Georgia Arrhythmia Consultants and Research Institute

    Macon, Georgia 31201
    United States

    Site Not Available

  • Memorial Health University Medical Center

    Savannah, Georgia 31404
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • The Kansas City Heart Rhythm Institute

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Baptist Health Lexington

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • Norton Heart Specialist

    Louisville, Kentucky 40205
    United States

    Site Not Available

  • Tulane University Heart & Vascular Institute

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Massachusetts General

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Trinity Health Michigan Heart - Ann Arbor Campus

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Cooper University Hospital

    Camden, New Jersey 08035
    United States

    Site Not Available

  • Cardiovascular Associates of the Delaware Valley

    Haddon Heights, New Jersey 08035
    United States

    Site Not Available

  • Lovelace Medical Center

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • New York University Heart Rhythm Center

    New York, New York 10016
    United States

    Site Not Available

  • New York University Langone Medical Center

    New York, New York 10016
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Ohio Health Research Institute

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • OhioHealth Mansfield Hospital

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Trident Medical Center

    North Charleston, South Carolina 29406
    United States

    Site Not Available

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas 78705
    United States

    Site Not Available

  • Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano

    Plano, Texas 75093
    United States

    Site Not Available

  • Methodist Texsan

    San Antonio, Texas 78201
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Site Not Available

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