RecruitingNCT04075084

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

BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

Sponsor

Biotronik SE & Co. KG

Enrollment

1,400 participants

Start Date

Oct 28, 2019

Study Type

OBSERVATIONAL

Conditions

Atrial Fibrillation Syncope Bradycardia Tachycardia Cryptogenic Stroke

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational registry is tracking patients who have a BIOTRONIK implantable cardiac monitor (ICM) — a small device inserted under the skin that continuously records the heart's electrical activity to detect irregular heart rhythms (arrhythmias). The study gathers real-world data on how the device performs and how patients do over time. **You may be eligible if...** - You are scheduled to receive a BIOTRONIK implantable cardiac monitor (ICM) - You are 18 years or older - You are able to use the CardioMessenger home monitoring device and are comfortable with remote heart monitoring - You understand the nature of the registry and can provide written consent **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are under 18 years old - You are already participating in another interventional clinical investigation (outside of BIO|STREAM.ICM sub-studies) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(31)

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

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