Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

Recruiting now

Conditions studied: Tachycardia, Atrial Fibrillation, Syncope, Bradycardia, Cryptogenic Stroke

In brief

This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up. In addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.

Key facts

Study ID

NCT04075084

Run by

Biotronik SE & Co. KG

People needed

1400

Starts

2019-10-28

Expected to finish

2027-08-30

Last updated by the study team

2025-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is intended to receive a BIOTRONIK Implantable Cardiac Monitor (ICM)
• 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.

You may not qualify if…

• Patient is pregnant or breast feeding.
• Patient is less than 18 years old.
• Patient is participating in another interventional clinical investigation other than the submodules of BIO\|STREAM.ICM

Where it is running

• Universitätsspital Zürich (USZ) — Zurich, Switzerland (enrolling)
• Ospedale Maria Vittoria — Torino, Italy (enrolling)
• Pauls Stradins Clinical University Hospital — Riga, Latvia (enrolling)
• Unidade Local de Saúde do Alto Ave, E. P. E. — Guimarães, Portugal (enrolling)
• Unidade Local de Saúde de Santa Maria, E. P. E. — Lisbon, Portugal (enrolling)
• Centro Médico Teknon — Erandio, Spain (enrolling)
• Hospital Álvaro Cunqueiro — Vigo, Spain (enrolling)
• Hospital Universitario de Araba — Vitoria-Gasteiz, Spain (enrolling)
• Integral Health — Adelaide, Australia (enrolling)
• Nemocnice Ceske Budejovice, a.s. — České Budějovice, Czechia (enrolling)
• Le Centre Hospitalier Universitaire de Brest (CHRU Brest) — Brest, France (enrolling)
• Le Centre Hospitalier Universitaire de Caen (CHRU Caen) — Caen, France (enrolling)
• Hôpital Gabriel Montpied — Clermont-Ferrand, France (enrolling)
• Hôpital Haut Lévêque (CHU) — Pessac, France (enrolling)
• Hôpitaux Universitaires de Strasbourg — Strasbourg, France (enrolling)
• St. Marienkrankhaus Klinikum Westmünsterland GmbH — Ahaus, Germany (enrolling)
• Kerckhoff-Klinik GmbH — Bad Nauheim, Germany (enrolling)
• Helios Klinikum Erfurt — Erfurt, Germany (enrolling)
• Klinikum Herford — Herford, Germany (enrolling)
• Helios Health Institute GmbH — Leipzig, Germany (enrolling)
• Deutsches Herzzentrum der Charité — Mitte, Germany (enrolling)
• Deutsches Herzzentrum der Charité — Steglitz, Germany (enrolling)
• Ospedale Civile Ferrari — Castrovillari, Italy (enrolling)
• Royal Adelaide Hospital — Adelaide, Australia
• Hospital de Fuenlabrada — Fuenlabrada, Spain

Full record on ClinicalTrials.gov

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