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An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias
Sponsor: Biosense Webster, Inc.
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
8000
Start Date
2021-02-22
Completion Date
2037-12-31
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (38)
Medical University of Graz
Graz, Austria
Ordensklinikum Linz GMBH
Linz, Austria
NÖ Landesgesundheitsagentur
Sankt Pölten, 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
Justus-Liebig-University Giessen
Giessen, 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
Clinica Mediterranea
Naples, Italy
Clinical Trial Center Maastricht
Maastricht, Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands
Hospital de Santa Cruz
Carnaxide, Portugal
Sahlgrenska University Hospital
Gothenburg, Sweden
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