A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator

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

Phase

N/A

Condition

Chest Pain

Atrial Fibrillation

Cardiac Disease

Treatment

OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator

Clinical Study ID

NCT05971693
BWI202201
BWI202201
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE Bi-directional 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 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)

  • 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/m^2}]), renal insufficiency (with an estimated creatinine clearanceless than (<) 30 milliliters per minute per 1.73 meter square [mL/min/1.73 m^2])

  • Previous left atrium (LA) ablation or surgery

  • Participants known to require ablation outside the PV region (example,atrioventricular reentrant tachycardia, atrioventricular nodal re-entry tachycardia,atrial tachycardia, ventricular tachycardia and Wolff-Parkinson-White)

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

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

  • Presence of LA thrombus

  • Severely compromised left ventricular ejection fraction (left ventricular ejectionfraction [LVEF] <40 percentage [%])

  • 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 transient ischemic attack [TIA]) within the past 6 months

  • Previous percutaneous coronary intervention (PCI) / myocardial infarction (MI)within the past 2 months

  • Previous coronary artery bypass grafting (CABG) in conjunction with valvularsurgery, cardiac surgery (example, ventriculotomy, atriotomy) or valvular cardiac (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 (example, restrictive pulmonary disease, constrictiveor chronic obstructive pulmonary disease) or any other disease or malfunction of thelungs or respiratory system that produces severe chronic symptoms

  • Known significant pulmonary vein (PV) anomaly that in the opinion of theinvestigator would preclude 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

  • Presence of implanted pacemaker or implantable cardioverter-defibrillator (ICD) orother implanted metal cardiac device that may interfere with the pulsed electricfield energy

  • Presence of a condition that precludes vascular access (such as Inferior Vena Cava [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 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)

  • Known contraindication for magnetic resonance imaging (MRI) such as use of contrastagents due to advanced renal disease, claustrophobia etcetra. (at principleinvestigator [PI] discretion)

  • Presence of iron-containing metal fragments in the body

  • Known unresolved pre-existing neurological deficit

  • Known uncontrolled significant gastroesophageal reflux disease (GERD)

Study Design

Total Participants: 149
Treatment Group(s): 1
Primary Treatment: OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator
Phase:
Study Start date:
September 12, 2023
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • O L V Ziekenhuis

    Aalst, 9300
    Belgium

    Site Not Available

  • O.L.V. Ziekenhuis

    Aalst, 9300
    Belgium

    Active - Recruiting

  • AZ Sint-Jan

    Brugge, 8000
    Belgium

    Site Not Available

  • Ziekenhuis Oost-Limburg

    Genk, 3600
    Belgium

    Site Not Available

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, 3500
    Belgium

    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

  • KBC Split

    Split, 21000
    Croatia

    Site Not Available

  • IKEM

    Prague, 140 21
    Czechia

    Site Not Available

  • Nemocnice na Homolce

    Prague, 150 30 District 5
    Czechia

    Site Not Available

  • MVZ CCB Frankfurt und Main Taunus GbR

    Frankfurt a.M., 60431
    Germany

    Site Not Available

  • Generale Regionale F. Miulli

    Acquaviva delle Fonti, 70021
    Italy

    Site Not Available

  • Vilnius University

    Vilnius, 08661
    Lithuania

    Site Not Available

  • Vilnius University Hospital Santariskiu Klinikos

    Vilnius, 08661
    Lithuania

    Site Not Available

  • Maastricht UMC

    Maastricht, 6229 HX
    Netherlands

    Site Not Available

  • Maastricht UMC+

    Maastricht, 6229 HX
    Netherlands

    Active - Recruiting

  • Luzerner Kantonsspital

    Luzern 16, 6000
    Switzerland

    Site Not Available

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