An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias
Launched by BIOSENSE WEBSTER, INC. · Feb 8, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the safety and effectiveness of certain medical devices made by Biosense Webster (BWI) that are used to treat heart rhythm problems, known as cardiac arrhythmias. The trial aims to collect data on how well these devices work during routine procedures called mapping and ablation, which are performed on patients with conditions like Atrial Fibrillation (AF) or other types of rapid heartbeats. By gathering this information, the researchers hope to confirm that these devices are safe and effective in everyday use.
To be eligible for this study, participants need to have been diagnosed with specific heart rhythm issues and be scheduled for an ablation procedure using a BWI device. They should also be able to follow the required tests and procedures, and they must sign a consent form agreeing to participate. If someone is currently involved in another clinical trial or has certain health issues that make them unsuitable for the use of these devices, they won’t be able to join. Participants can expect to receive standard care while providing valuable information that could help improve treatment for heart rhythm problems in the future.
Gender
ALL
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
About Biosense Webster, Inc.
Biosense Webster, Inc., a subsidiary of Johnson & Johnson, is a leading innovator in the field of electrophysiology, specializing in advanced diagnostic and therapeutic solutions for cardiac arrhythmias. The company is dedicated to improving patient outcomes through cutting-edge technologies, including mapping systems and catheter-based therapies. With a robust commitment to clinical research and development, Biosense Webster actively sponsors clinical trials aimed at enhancing the understanding and treatment of heart rhythm disorders, ensuring that healthcare professionals have access to the most effective tools for patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
London, , United Kingdom
Leicester, , United Kingdom
Carnaxide, , Portugal
London, , United Kingdom
Aarhus, , Denmark
London, , United Kingdom
Brussels, , Belgium
Rotterdam, , Netherlands
Brugge, , Belgium
Jerusalem, , Israel
Edegem, , Belgium
Paris, , France
Aalst, , Belgium
Hasselt, , Belgium
Tel Aviv, , Israel
Graz, , Austria
Linz, , Austria
Acquaviva Delle Fonti, , Italy
Milan, , Italy
Talence, , France
Bad Neustadt An Der Saale, , Germany
Frankfurt, , Germany
Munich, , Germany
Jette, , Belgium
Dublin, , Ireland
La Louvière, , Belgium
Lyon, , France
Bern, , Switzerland
Bad Oeynhausen, , Germany
Maastricht, , Netherlands
Patients applied
Trial Officials
Biosense Webster, Inc. Clinical Trial
Study Director
Biosense Webster, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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