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

NCT04075084 · tracked via the Priya Life Science Germany tracker

Sponsor

Biotronik SE & Co. KG

Phase

Observational

Started

2019-10-28

Last updated

2025-10-01

Condition(s) studied

TachycardiaAtrial FibrillationSyncopeBradycardiaCryptogenic Stroke

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Primary outcome measure(s)

Time to diagnosis — The time to a relevant diagnosis can vary significantly. The time period starts with the insertion of the device.
Device is intended to detect rare arrhythmias. Time to detect this relevant arrhythmia will be recorded.

Trial sites (31)

Facility	City	Region	Status
Integral Health	Adelaide	Australia	Recruiting
Royal Adelaide Hospital	Adelaide	Australia	Completed
Nemocnice Ceske Budejovice, a.s.	České Budějovice	Czechia	Recruiting
Hôpital Saint-André	Bordeaux	France	Completed
Le Centre Hospitalier Universitaire de Brest (CHRU Brest)	Brest	France	Recruiting
Le Centre Hospitalier Universitaire de Caen (CHRU Caen)	Caen	France	Recruiting
Le Centre Hospitalier Universitaire de Tours (CHRU Tours)	Chambray-lès-Tours	France	Active Not Recruiting
Hôpital Gabriel Montpied	Clermont-Ferrand	France	Recruiting
Hôpital Haut Lévêque (CHU)	Pessac	France	Recruiting
Hôpitaux Universitaires de Strasbourg	Strasbourg	France	Recruiting
St. Marienkrankhaus Klinikum Westmünsterland GmbH	Ahaus	Germany	Recruiting
Kerckhoff-Klinik GmbH	Bad Nauheim	Germany	Recruiting
Rhön-Klinikum	Bad Neustadt an der Saale	Germany	Active Not Recruiting
Universitätsklinik an der Technischen Universität Dresden	Dresden	Germany	Completed
Helios Klinikum Erfurt	Erfurt	Germany	Recruiting
Klinikum Herford	Herford	Germany	Recruiting
Helios Health Institute GmbH	Leipzig	Germany	Recruiting
Deutsches Herzzentrum der Charité	Mitte	Germany	Recruiting
Klinikum rechts der Isar der Technischen Universität München	München	Germany	Active Not Recruiting
Deutsches Herzzentrum der Charité	Steglitz	Germany	Recruiting
Ospedale Civile Ferrari	Castrovillari	Italy	Recruiting
Ospedale Maria Vittoria	Torino	Italy	Recruiting
Pauls Stradins Clinical University Hospital	Riga	Latvia	Recruiting
Unidade Local de Saúde do Alto Ave, E. P. E.	Guimarães	Portugal	Recruiting
Unidade Local de Saúde de Santa Maria, E. P. E.	Lisbon	Portugal	Recruiting
Centro Médico Teknon	Erandio	Spain	Recruiting
Hospital de Fuenlabrada	Fuenlabrada	Spain	Active Not Recruiting
Hospital Álvaro Cunqueiro	Vigo	Spain	Recruiting
Hospital Universitario de Araba	Vitoria-Gasteiz	Spain	Recruiting
GZO Spital Wetzikon	Wetzikon	Switzerland	Completed
Universitätsspital Zürich (USZ)	Zurich	Switzerland	Recruiting

More Biotronik SE & Co. KG trials in Germany

Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products Recruiting

BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software Recruiting

BIO|STREAM.CSP Study Recruiting

BIO|MASTER.CorSky Family Post-market Study for the CorSky Family of ICDs Recruiting

Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices Active, not recruiting

Other trials for the same condition

Non-invasive Differentiation of Supraventricular Tachyarrhythmia Recruiting

Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers Recruiting

Clinical Cohort Study - TRUST Recruiting

Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE Recruiting

VOLT CE Mark Study Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04075084 on ClinicalTrials.gov ↗ ← All trials in Germany