An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias

Last updated: January 15, 2026
Sponsor: Biosense Webster, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiac Disease

Circulation Disorders

Treatment

Varipulse Catheter

BWI Medical Device

Dual Energy THERMOCOOL SMARTTOUCH SF Catheter

Clinical Study ID

NCT04750798
BWI_2019_05
BWI_2019_05
  • All Genders

Study Summary

The purpose of this study is to prospectively collect clinical data evaluating the ongoing safety and performance during routine-use standard cardiac arrhythmia mapping and/or ablation procedures while using commercial Biosense Webster Inc. (BWI) medical devices. Data generated from the study will be used to confirm safety and performance of BWI medical devices in the marketed phase and to expand the body of evidence on the use of these devices and techniques in treatment of cardiac arrhythmias.

Eligibility Criteria

Inclusion

Inclusion criteria

  • Diagnosed with paroxysmal or persistent Atrial Fibrillation (AF) or supraventriculartachycardia (SVT) or ventricular tachycardia (VT) and scheduled to undergo anablation procedure for management of their arrhythmia with a per-protocol defined BWtherapeutic catheter

  • Able and willing to comply with all pre, post and follow-up testing and requirementsas per hospital standard of care

  • Signed patient informed consent form (ICF) as applicable per local regulation

Exclusion

Exclusion criteria:

  • Currently participating in an interventional (drug, device, biologic) clinical trial

  • Life expectancy of less than 12-months

  • Presenting any contraindication for the use of BWI commercially approved medicaldevices, as indicated in the respective user manuals

Study Design

Total Participants: 8000
Treatment Group(s): 3
Primary Treatment: Varipulse Catheter
Phase:
Study Start date:
February 22, 2021
Estimated Completion Date:
December 31, 2037

Connect with a study center

  • Medical University of Graz

    Graz, 8010
    Austria

    Site Not Available

  • Medical University of Graz

    Graz 2778067, 8010
    Austria

    Active - Recruiting

  • Ordensklinikum Linz GMBH

    Linz, 4020
    Austria

    Site Not Available

  • Ordensklinikum Linz GMBH

    Linz 2772400, 4020
    Austria

    Active - Recruiting

  • OLV Aalst

    Aalst, 9300
    Belgium

    Site Not Available

  • OLV Aalst

    Aalst 2803448, 9300
    Belgium

    Active - Recruiting

  • AZ Sint-Jan Brugge

    Bruges 2800931, 8000
    Belgium

    Active - Recruiting

  • AZ Sint-Jan Brugge

    Brugge, 8000
    Belgium

    Site Not Available

  • CHU Saint-Pierre

    Brussels, 1000
    Belgium

    Site Not Available

  • CHU Saint-Pierre

    Brussels 2800866, 1000
    Belgium

    Active - Recruiting

  • UZ Antwerp

    Edegem, 2650
    Belgium

    Site Not Available

  • UZ Antwerp

    Edegem 2799007, 2650
    Belgium

    Active - Recruiting

  • Jessa Hospital

    Hasselt, 3500
    Belgium

    Site Not Available

  • Jessa Hospital

    Hasselt 2796491, 3500
    Belgium

    Active - Recruiting

  • UZ Brussels

    Jette, 1090
    Belgium

    Site Not Available

  • UZ Brussels

    Jette 2794914, 1090
    Belgium

    Active - Recruiting

  • ASBL CHU HELORA Hôpital de La Louvière site Jolimont

    La Louvière, 7100
    Belgium

    Site Not Available

  • ASBL CHU HELORA Hôpital de La Louvière site Jolimont

    La Louvière 2793508, 7100
    Belgium

    Active - Recruiting

  • Aarhus University Hospital

    Aarhus, 8200
    Denmark

    Site Not Available

  • Aarhus University Hospital

    Aarhus 2624652, 8200
    Denmark

    Active - Recruiting

  • Rigshospitalet

    Copenhagen 2618425, 2100
    Denmark

    Active - Recruiting

  • Les Hospices Civils de Lyon

    Lyon, 69002
    France

    Site Not Available

  • Les Hospices Civils de Lyon

    Lyon 2996944, 69002
    France

    Active - Recruiting

  • Hôpital Saint Joseph de Marseille

    Marseille 2995469, 13285
    France

    Active - Recruiting

  • Institut Mutualiste Montsouris

    Paris, 75674
    France

    Site Not Available

  • Institut Mutualiste Montsouris

    Paris 2988507, 75674
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Bordeaux

    Talence, 33404
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Bordeaux

    Talence 2973495, 33404
    France

    Active - Recruiting

  • Rhön-Klinikum Campus Bad Neustadt

    Bad Neustadt an der Saale, 97616
    Germany

    Site Not Available

  • Rhön-Klinikum Campus Bad Neustadt

    Bad Neustadt an der Saale 2953389, 97616
    Germany

    Active - Recruiting

  • Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum

    Bad Oeynhausen, 3245
    Germany

    Site Not Available

  • Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum

    Bad Oeynhausen 2953386, 3245
    Germany

    Active - Recruiting

  • Segeberger Kliniken

    Bad Segeberg, 23795
    Germany

    Site Not Available

  • Segeberger Kliniken

    Bad Segeberg 2953341, 23795
    Germany

    Active - Recruiting

  • Alfried Krupp Hospital

    Essen, 45131
    Germany

    Site Not Available

  • Alfried Krupp Hospital

    Essen 2928810, 45131
    Germany

    Active - Recruiting

  • Cardioangiologisches Centrum Bethanien (CCB)

    Frankfurt, 60431
    Germany

    Site Not Available

  • Cardioangiologisches Centrum Bethanien (CCB)

    Frankfurt 2925536, 60431
    Germany

    Active - Recruiting

  • German Heart Centre Munich

    Munich, 80636
    Germany

    Site Not Available

  • German Heart Centre Munich

    Munich 2867714, 80636
    Germany

    Active - Recruiting

  • Mater Private Heart and Vascular Centre

    Dublin, D07 WKW8
    Ireland

    Site Not Available

  • Mater Private Heart and Vascular Centre

    Dublin 2964574, D07 WKW8
    Ireland

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9103102
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem 281184, 9103102
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv 293397, 6423906
    Israel

    Active - Recruiting

  • Ospedale Generale Regionale "F. Miulli"

    Acquaviva delle Fonti, 70021
    Italy

    Site Not Available

  • Ospedale Generale Regionale "F. Miulli"

    Acquaviva delle Fonti 3183494, 70021
    Italy

    Active - Recruiting

  • IRCCS Policlinico San Donato

    Milan, 20097
    Italy

    Site Not Available

  • IRCCS Policlinico San Donato

    Milan 3173435, 20097
    Italy

    Active - Recruiting

  • Clinical Trial Center Maastricht

    Maastricht, 6229 EV
    Netherlands

    Site Not Available

  • Clinical Trial Center Maastricht

    Maastricht 2751283, 6229 EV
    Netherlands

    Active - Recruiting

  • Erasmus University Medical Center

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Erasmus University Medical Center

    Rotterdam 2747891, 3015 GD
    Netherlands

    Active - Recruiting

  • Hospital de Santa Cruz

    Carnaxide, 2790-134
    Portugal

    Site Not Available

  • Hospital de Santa Cruz

    Carnaxide 2270157, 2790-134
    Portugal

    Active - Recruiting

  • INSELSPITAL Universitätsspital Bern

    Bern, 03010
    Switzerland

    Site Not Available

  • INSELSPITAL Universitätsspital Bern

    Bern 2661552, 03010
    Switzerland

    Active - Recruiting

  • Glenfield Hospital

    Leicester, LE3 9QP
    United Kingdom

    Site Not Available

  • Glenfield Hospital

    Leicester 2644668, LE3 9QP
    United Kingdom

    Active - Recruiting

  • Royal Brompton Hospital

    London, SW3 6NP
    United Kingdom

    Site Not Available

  • St George's Hospital

    London, SW17 0QT
    United Kingdom

    Active - Recruiting

  • St. Bartholomew's Hospital

    London, EC1A 7BE
    United Kingdom

    Completed

  • Royal Brompton Hospital

    London 2643743, SW3 6NP
    United Kingdom

    Active - Recruiting

  • St George's Hospital

    London 2643743, SW17 0QT
    United Kingdom

    Active - Recruiting

  • St. Bartholomew's Hospital

    London 2643743, EC1A 7BE
    United Kingdom

    Completed

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