Actively Recruiting

All Genders
NCT04750798

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

Led by Biosense Webster, Inc. · Updated on 2026-05-08

8000

Participants Needed

39

Research Sites

879 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with paroxysmal or persistent Atrial Fibrillation (AF) or supraventricular tachycardia (SVT) or ventricular tachycardia (VT) and scheduled to undergo an ablation procedure for management of their arrhythmia with a per-protocol defined BW therapeutic catheter
  • Able and willing to comply with all pre, post and follow-up testing and requirements as per hospital standard of care
  • Signed patient informed consent form (ICF) as applicable per local regulation
Not Eligible

You will not qualify if you...

  • 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 medical devices, as indicated in the respective user manuals

AI-Screening

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Trial Site Locations

Total: 39 locations

1

Medical University of Graz

Graz, Austria, 8010

Actively Recruiting

2

Ordensklinikum Linz GMBH

Linz, Austria, 4020

Actively Recruiting

3

NÖ Landesgesundheitsagentur

Sankt Pölten, Austria, 3100

Actively Recruiting

4

OLV Aalst

Aalst, Belgium, 9300

Actively Recruiting

5

AZ Sint-Jan Brugge

Bruges, Belgium, 8000

Actively Recruiting

6

CHU Saint-Pierre

Brussels, Belgium, 1000

Actively Recruiting

7

UZ Antwerp

Edegem, Belgium, 2650

Actively Recruiting

8

Jessa Hospital

Hasselt, Belgium, 3500

Actively Recruiting

9

UZ Brussels

Jette, Belgium, 1090

Actively Recruiting

10

ASBL CHU HELORA Hôpital de La Louvière site Jolimont

La Louvière, Belgium, 7100

Actively Recruiting

11

Aarhus University Hospital

Aarhus, Denmark, 8200

Actively Recruiting

12

Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

13

Les Hospices Civils de Lyon

Lyon, France, 69002

Actively Recruiting

14

Hôpital Saint Joseph de Marseille

Marseille, France, 13285

Actively Recruiting

15

Institut Mutualiste Montsouris

Paris, France, 75674

Actively Recruiting

16

Centre Hospitalier Universitaire de Bordeaux

Talence, France, 33404

Actively Recruiting

17

Rhön-Klinikum Campus Bad Neustadt

Bad Neustadt an der Saale, Germany, 97616

Actively Recruiting

18

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

Bad Oeynhausen, Germany, 3245

Actively Recruiting

19

Segeberger Kliniken

Bad Segeberg, Germany, 23795

Actively Recruiting

20

Alfried Krupp Hospital

Essen, Germany, 45131

Actively Recruiting

21

Cardioangiologisches Centrum Bethanien (CCB)

Frankfurt, Germany, 60431

Actively Recruiting

22

Justus-Liebig-University Giessen

Giessen, Germany, 35390

Actively Recruiting

23

Asklepios Klinik Altona

Hamburg, Germany, 22763

Actively Recruiting

24

German Heart Centre Munich

Munich, Germany, 80636

Actively Recruiting

25

Mater Private Heart and Vascular Centre

Dublin, Ireland, D07 WKW8

Actively Recruiting

26

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

Actively Recruiting

27

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 6423906

Actively Recruiting

28

Ospedale Generale Regionale "F. Miulli"

Acquaviva delle Fonti, Italy, 70021

Actively Recruiting

29

IRCCS Policlinico San Donato

Milan, Italy, 20097

Actively Recruiting

30

Clinica Mediterranea

Naples, Italy, 80122

Actively Recruiting

31

Clinical Trial Center Maastricht

Maastricht, Netherlands, 6229 EV

Actively Recruiting

32

Erasmus University Medical Center

Rotterdam, Netherlands, 3015 GD

Actively Recruiting

33

Hospital de Santa Cruz

Carnaxide, Portugal, 2790-134

Actively Recruiting

34

Sahlgrenska University Hospital

Gothenburg, Sweden, 413 45

Actively Recruiting

35

INSELSPITAL Universitätsspital Bern

Bern, Switzerland, 03010

Actively Recruiting

36

Glenfield Hospital

Leicester, United Kingdom, LE3 9QP

Actively Recruiting

37

St. Bartholomew's Hospital

London, United Kingdom, EC1A 7BE

Completed

38

St George's Hospital

London, United Kingdom, SW17 0QT

Actively Recruiting

39

Royal Brompton Hospital

London, United Kingdom, SW3 6NP

Actively Recruiting

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Research Team

N

Nathalie Macours

CONTACT

L

Liesbeth Gorissen

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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