Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
NCT ID: NCT04075084
Last Updated: 2025-10-01
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
1400 participants
OBSERVATIONAL
2019-10-28
2027-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patient is able to understand the nature of the registry and to provide written informed consent.
* Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.
Exclusion Criteria
* Patient is less than 18 years old.
* Patient is participating in another interventional clinical investigation other than the submodules of BIO\|STREAM.ICM
18 Years
ALL
No
Sponsors
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Biotronik SE & Co. KG
INDUSTRY
Responsible Party
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Locations
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Integral Health
Adelaide, , Australia
Royal Adelaide Hospital
Adelaide, , Australia
Nemocnice Ceske Budejovice, a.s.
České Budějovice, , Czechia
Hôpital Saint-André
Bordeaux, , France
Le Centre Hospitalier Universitaire de Brest (CHRU Brest)
Brest, , France
Le Centre Hospitalier Universitaire de Caen (CHRU Caen)
Caen, , France
Le Centre Hospitalier Universitaire de Tours (CHRU Tours)
Chambray-lès-Tours, , France
Hôpital Gabriel Montpied
Clermont-Ferrand, , France
Hôpital Haut Lévêque (CHU)
Pessac, , France
Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
St. Marienkrankhaus Klinikum Westmünsterland GmbH
Ahaus, , Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, , Germany
Rhön-Klinikum
Bad Neustadt an der Saale, , Germany
Universitätsklinik an der Technischen Universität Dresden
Dresden, , Germany
Helios Klinikum Erfurt
Erfurt, , Germany
Klinikum Herford
Herford, , Germany
Helios Health Institute GmbH
Leipzig, , Germany
Deutsches Herzzentrum der Charité
Mitte, , Germany
Klinikum rechts der Isar der Technischen Universität München
München, , Germany
Deutsches Herzzentrum der Charité
Steglitz, , Germany
Ospedale Civile Ferrari
Castrovillari, , Italy
Ospedale Maria Vittoria
Torino, , Italy
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Unidade Local de Saúde do Alto Ave, E. P. E.
Guimarães, , Portugal
Unidade Local de Saúde de Santa Maria, E. P. E.
Lisbon, , Portugal
Centro Médico Teknon
Erandio, , Spain
Hospital de Fuenlabrada
Fuenlabrada, , Spain
Hospital Álvaro Cunqueiro
Vigo, , Spain
Hospital Universitario de Araba
Vitoria-Gasteiz, , Spain
GZO Spital Wetzikon
Wetzikon, , Switzerland
Universitätsspital Zürich (USZ)
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Dennis Lau, Dr.
Role: primary
Alan Bulava, Prof.
Role: primary
Jacques Mansourati, Pr.
Role: primary
Virgine Ferchaud, Dr
Role: primary
Romain Eschalier, Pr.
Role: primary
Sylvain Ploux, Pr.
Role: primary
Laurence Jesel-Morel, Dr.
Role: primary
Alessandro Cueno, Dr.
Role: primary
Andreas Hain, Dr.
Role: primary
Frank Steinborn, Dr.
Role: primary
Jan Kähler, Prof. Dr.
Role: primary
Sotirios Nedios, Dr.
Role: primary
Verena Tscholl, Dr.
Role: primary
Patrick Nagel, Dr.
Role: primary
Giovanni Bisignani, Dr.
Role: primary
Massimo Giammaria, Dr.
Role: primary
Andrejs Erglis, Prof
Role: primary
Victor M. Sanfins, Dr.
Role: primary
João de Sousa, Dr.
Role: primary
Antonio Berruezo Sanchez, Dr.
Role: primary
Pilar Cabanas, Dr.
Role: primary
Enrique Garcia, Dr.
Role: primary
Daniel Hofer, Dr.
Role: primary
References
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Bisignani G, De Bonis S, Pierre B, Lau DH, Hofer D, Sanfins VM, Hain A, Cabanas P, Martens E, Berruezo A, Eschalier R, Milliez P, Lusebrink U, Mansourati J, Papaioannou G, Giacopelli D, Gargaro A, Ploux S. Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety. Front Cardiovasc Med. 2023 Mar 21;10:1148052. doi: 10.3389/fcvm.2023.1148052. eCollection 2023.
Other Identifiers
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HS061
Identifier Type: -
Identifier Source: org_study_id
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