Actively Recruiting

Age: 18Years +
All Genders
NCT04075084

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

Led by Biotronik SE & Co. KG · Updated on 2025-10-01

1400

Participants Needed

31

Research Sites

409 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 31 locations

1

Integral Health

Adelaide, Australia

Actively Recruiting

2

Royal Adelaide Hospital

Adelaide, Australia

Completed

3

Nemocnice Ceske Budejovice, a.s.

České Budějovice, Czechia, 37001

Actively Recruiting

4

Hôpital Saint-André

Bordeaux, France

Completed

5

Le Centre Hospitalier Universitaire de Brest (CHRU Brest)

Brest, France

Actively Recruiting

6

Le Centre Hospitalier Universitaire de Caen (CHRU Caen)

Caen, France

Actively Recruiting

7

Le Centre Hospitalier Universitaire de Tours (CHRU Tours)

Chambray-lès-Tours, France

Active, Not Recruiting

8

Hôpital Gabriel Montpied

Clermont-Ferrand, France

Actively Recruiting

9

Hôpital Haut Lévêque (CHU)

Pessac, France

Actively Recruiting

10

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Actively Recruiting

11

St. Marienkrankhaus Klinikum Westmünsterland GmbH

Ahaus, Germany

Actively Recruiting

12

Kerckhoff-Klinik GmbH

Bad Nauheim, Germany

Actively Recruiting

13

Rhön-Klinikum

Bad Neustadt an der Saale, Germany

Active, Not Recruiting

14

Universitätsklinik an der Technischen Universität Dresden

Dresden, Germany

Completed

15

Helios Klinikum Erfurt

Erfurt, Germany

Actively Recruiting

16

Klinikum Herford

Herford, Germany

Actively Recruiting

17

Helios Health Institute GmbH

Leipzig, Germany

Actively Recruiting

18

Deutsches Herzzentrum der Charité

Mitte, Germany

Actively Recruiting

19

Klinikum rechts der Isar der Technischen Universität München

München, Germany

Active, Not Recruiting

20

Deutsches Herzzentrum der Charité

Steglitz, Germany

Actively Recruiting

21

Ospedale Civile Ferrari

Castrovillari, Italy

Actively Recruiting

22

Ospedale Maria Vittoria

Torino, Italy

Actively Recruiting

23

Pauls Stradins Clinical University Hospital

Riga, Latvia, 1002

Actively Recruiting

24

Unidade Local de Saúde do Alto Ave, E. P. E.

Guimarães, Portugal

Actively Recruiting

25

Unidade Local de Saúde de Santa Maria, E. P. E.

Lisbon, Portugal

Actively Recruiting

26

Centro Médico Teknon

Erandio, Spain

Actively Recruiting

27

Hospital de Fuenlabrada

Fuenlabrada, Spain

Active, Not Recruiting

28

Hospital Álvaro Cunqueiro

Vigo, Spain

Actively Recruiting

29

Hospital Universitario de Araba

Vitoria-Gasteiz, Spain

Actively Recruiting

30

GZO Spital Wetzikon

Wetzikon, Switzerland

Completed

31

Universitätsspital Zürich (USZ)

Zurich, Switzerland

Actively Recruiting

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Research Team

S

Sabrina Hoche, Dr.

CONTACT

D

Dörte Vossmeyer, Dr.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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