An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias
NCT ID: NCT04750798
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
8000 participants
OBSERVATIONAL
2021-02-22
2037-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants Diagnosed with Cardiac Arrhythmias
Patients diagnosed with cardiac arrhythmias who are scheduled to undergo an ablation procedure in routine clinical practice for management of their arrhythmia with a BWI therapeutic catheter/Varipulse Catheter/ Dual Energy Thermocool Smarttouch surround flow (SF) catheter will be observed.
Dual Energy THERMOCOOL SMARTTOUCH SF Catheter
Participants treated with the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter in the main study will be part of the DUACURE sub-study. No specific intervention will be observed for this study.
BWI Medical Device
Participants will be treated with commercially approved BWI medical devices following routine clinical practice. No specific intervention will be observed for this study.
Varipulse Catheter
Participants treated with Varipulse Catheter in the main study will be part of the VARIPURE sub-study. No specific intervention will be observed for this study.
Interventions
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Dual Energy THERMOCOOL SMARTTOUCH SF Catheter
Participants treated with the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter in the main study will be part of the DUACURE sub-study. No specific intervention will be observed for this study.
BWI Medical Device
Participants will be treated with commercially approved BWI medical devices following routine clinical practice. No specific intervention will be observed for this study.
Varipulse Catheter
Participants treated with Varipulse Catheter in the main study will be part of the VARIPURE sub-study. No specific intervention will be observed for this study.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Biosense Webster, Inc. Clinical Trial
Role: STUDY_DIRECTOR
Biosense Webster, Inc.
Locations
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Medical University of Graz
Graz, , Austria
Ordensklinikum Linz GMBH
Linz, , Austria
OLV Aalst
Aalst, , Belgium
AZ Sint-Jan Brugge
Bruges, , Belgium
CHU Saint-Pierre
Brussels, , Belgium
UZ Antwerp
Edegem, , Belgium
Jessa Hospital
Hasselt, , Belgium
UZ Brussels
Jette, , Belgium
ASBL CHU HELORA Hôpital de La Louvière site Jolimont
La Louvière, , Belgium
Aarhus University Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Les Hospices Civils de Lyon
Lyon, , France
Hôpital Saint Joseph de Marseille
Marseille, , France
Institut Mutualiste Montsouris
Paris, , France
Centre Hospitalier Universitaire de Bordeaux
Talence, , France
Rhön-Klinikum Campus Bad Neustadt
Bad Neustadt an der Saale, , Germany
Herz- und Diabeteszentrum NRW, University Hospital of the Ruhr University Bochum
Bad Oeynhausen, , Germany
Segeberger Kliniken
Bad Segeberg, , Germany
Alfried Krupp Hospital
Essen, , Germany
Cardioangiologisches Centrum Bethanien (CCB)
Frankfurt, , Germany
German Heart Centre Munich
Munich, , Germany
Mater Private Heart and Vascular Centre
Dublin, , Ireland
Shaare Zedek Medical Center
Jerusalem, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Ospedale Generale Regionale "F. Miulli"
Acquaviva delle Fonti, , Italy
IRCCS Policlinico San Donato
Milan, , Italy
Clinical Trial Center Maastricht
Maastricht, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Hospital de Santa Cruz
Carnaxide, , Portugal
INSELSPITAL Universitätsspital Bern
Bern, , Switzerland
Glenfield Hospital
Leicester, , United Kingdom
St. Bartholomew's Hospital
London, , United Kingdom
St George's Hospital
London, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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BWI_2019_05
Identifier Type: -
Identifier Source: org_study_id
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