An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias
An Observational Post-marketing Study for Evaluation of Ongoing Safety and Effectiveness of Catheter Mapping and Ablation Using Commercially Approved BWI Medical Devices for the Treatment of Patients With Cardiac Arrhythmias
- Arrhythmias, Cardiac
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Biosense Webster, Inc.
- Enrolment target
- 8,000
- Started
- 22 February 2021
- Main results due
- 31 December 2036
- Study sites
- 46
- Registry updated
- 25 September 2026
Can you take part?
- No age limit is stated.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion criteria * 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 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 medical devices, as indicated in the respective user manuals
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(46)
Medical University of Graz
Graz, Austria
Recruiting
Ordensklinikum Linz GMBH
Linz, Austria
Recruiting
Universitätsklinikum Wiener Neustadt
Wiener Neustadt, Austria
Recruiting
OLV Aalst
Aalst, Belgium
Recruiting
AZ Sint-Jan Brugge
Bruges, Belgium
Recruiting
CHU Saint-Pierre
Brussels, Belgium
Recruiting
UZ Antwerp
Edegem, Belgium
Recruiting
Jessa Hospital
Hasselt, Belgium
Recruiting
UZ Brussels
Jette, Belgium
Recruiting
ASBL CHU HELORA Hôpital de La Louvière site Jolimont
La Louvière, Belgium
Recruiting
Aarhus University Hospital
Aarhus, Denmark
Recruiting
Rigshospitalet
Copenhagen, Denmark
Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Recruiting
Les Hospices Civils de Lyon
Lyon, France
Recruiting
Hôpital Saint Joseph de Marseille
Marseille, France
Recruiting
Institut Mutualiste Montsouris
Paris, France
Recruiting
CHU de Rennes
Rennes, France
Recruiting
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Recruiting
Centre Hospitalier Universitaire de Bordeaux
Talence, France
Recruiting
Rhön-Klinikum Campus Bad Neustadt
Bad Neustadt an der Saale, Germany
Recruiting
Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum
Bad Oeynhausen, Germany
Recruiting
Segeberger Kliniken
Bad Segeberg, Germany
Recruiting
Oberlausitz-Kliniken
Bautzen, Germany
Recruiting
Alfried Krupp Hospital
Essen, Germany
Recruiting
Cardioangiologisches Centrum Bethanien (CCB)
Frankfurt, Germany
Completed
Justus-Liebig-University Giessen
Giessen, Germany
Recruiting
Asklepios Klinik Altona
Hamburg, Germany
Recruiting
German Heart Centre Munich
Munich, Germany
Recruiting
Semmelweis University
Budapest, Hungary
Recruiting
Mater Private Heart and Vascular Centre
Dublin, Ireland
Recruiting
Shaare Zedek Medical Center
Jerusalem, Israel
Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Completed
Ospedale Generale Regionale "F. Miulli"
Acquaviva delle Fonti, Italy
Recruiting
A.O. Universitaria Delle Marche
Ancona, Italy
Recruiting
IRCCS Policlinico San Donato
Milan, Italy
Recruiting
Clinica Mediterranea
Naples, Italy
Recruiting
Clinical Trial Center Maastricht
Maastricht, Netherlands
Recruiting
Erasmus University Medical Center
Rotterdam, Netherlands
Recruiting
Haukeland University Hospital
Bergen, Norway
Recruiting
Hospital de Santa Cruz
Carnaxide, Portugal
Recruiting
Sahlgrenska University Hospital
Gothenburg, Sweden
Recruiting
INSELSPITAL Universitätsspital Bern
Bern, Switzerland
Recruiting
Glenfield Hospital
Leicester, United Kingdom
Recruiting
St. Bartholomew's Hospital
London, United Kingdom
Completed
St George's Hospital
London, United Kingdom
Recruiting
Royal Brompton Hospital
London, United Kingdom
Recruiting
Showing 46 of 46 sites. 43 of the 46 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT04750798. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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