An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias
Recruiting now
Conditions studied: Arrhythmias, Cardiac
In brief
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.
Key facts
- Study ID
- NCT04750798
- Run by
- Biosense Webster, Inc.
- People needed
- 8000
- Starts
- 2021-02-22
- Expected to finish
- 2037-12-31
- Last updated by the study team
- 2026-07-06
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Royal Brompton Hospital — London, United Kingdom (enrolling)
- Ordensklinikum Linz GMBH — Linz, Austria (enrolling)
- Universitätsklinikum Wiener Neustadt — Wiener Neustadt, Austria (enrolling)
- OLV Aalst — Aalst, Belgium (enrolling)
- AZ Sint-Jan Brugge — Bruges, Belgium (enrolling)
- CHU Saint-Pierre — Brussels, Belgium (enrolling)
- UZ Antwerp — Edegem, Belgium (enrolling)
- Jessa Hospital — Hasselt, Belgium (enrolling)
- UZ Brussels — Jette, Belgium (enrolling)
- ASBL CHU HELORA Hôpital de La Louvière site Jolimont — La Louvière, Belgium (enrolling)
- Aarhus University Hospital — Aarhus, Denmark (enrolling)
- Rigshospitalet — Copenhagen, Denmark (enrolling)
- Les Hospices Civils de Lyon — Lyon, France (enrolling)
- Hôpital Saint Joseph de Marseille — Marseille, France (enrolling)
- Institut Mutualiste Montsouris — Paris, France (enrolling)
- Les Hôpitaux Universitaires de Strasbourg — Strasbourg, France (enrolling)
- Centre Hospitalier Universitaire de Bordeaux — Talence, France (enrolling)
- Rhön-Klinikum Campus Bad Neustadt — Bad Neustadt an der Saale, Germany (enrolling)
- Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum — Bad Oeynhausen, Germany (enrolling)
- Segeberger Kliniken — Bad Segeberg, Germany (enrolling)
- Alfried Krupp Hospital — Essen, Germany (enrolling)
- St George's Hospital — London, United Kingdom (enrolling)
- Medical University of Graz — Graz, Austria (enrolling)
- Justus-Liebig-University Giessen — Giessen, Germany (enrolling)
- Asklepios Klinik Altona — Hamburg, Germany (enrolling)
Full record on ClinicalTrials.gov
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