Fact CheckerSign in

NCT04075084Recruiting

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)

Source: ClinicalTrials.gov · Last updated 1 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1400 (estimated)
First submitted
8 Aug 2019
Start date
Oct 2019
Primary completion date
May 2027
Lead sponsor
Biotronik SE & Co. KG
NCT number
NCT04075084

What you commit to

  • Study type: Observational
  • Planned participants: 1400
  • From Oct 2019 to the primary completion date, May 2027
  • 31 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Patient is less than 18 years old.

Other

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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (31)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Integral Health
Coordinator of this site? Confirm its status
AdelaideAustraliaRecruiting
Royal Adelaide Hospital
Coordinator of this site? Confirm its status
AdelaideAustraliaCompleted
GZO Spital Wetzikon
Coordinator of this site? Confirm its status
WetzikonSwitzerlandCompleted
Universitätsspital Zürich USZ
Coordinator of this site? Confirm its status
ZurichSwitzerlandRecruiting
Nemocnice České Budějovice, a.s.
Coordinator of this site? Confirm its status
České BudějoviceCzechiaRecruiting
St. Marienkrankhaus Klinikum Westmünsterland GmbH
Coordinator of this site? Confirm its status
AhausGermanyRecruiting
Kerckhoff-Klinik GmbH
Coordinator of this site? Confirm its status
Bad NauheimGermanyRecruiting
Rhön-Klinikum
Coordinator of this site? Confirm its status
Bad Neustadt an der SaaleGermanyActive, not recruiting
Universitätsklinik an der Technischen Universität Dresden
Coordinator of this site? Confirm its status
DresdenGermanyCompleted
Helios Klinikum Erfurt
Coordinator of this site? Confirm its status
ErfurtGermanyRecruiting
Klinikum Herford
Coordinator of this site? Confirm its status
HerfordGermanyRecruiting
Helios Health Institute GmbH
Coordinator of this site? Confirm its status
LeipzigGermanyRecruiting
Deutsches Herzzentrum der Charité
Coordinator of this site? Confirm its status
MitteGermanyRecruiting
Klinikum rechts der Isar der Technischen Universität München
Coordinator of this site? Confirm its status
MünchenGermanyActive, not recruiting
Deutsches Herzzentrum der Charité
Coordinator of this site? Confirm its status
SteglitzGermanyRecruiting
Centro Médico Teknon
Coordinator of this site? Confirm its status
ErandioSpainRecruiting
Hospital de Fuenlabrada
Coordinator of this site? Confirm its status
FuenlabradaSpainActive, not recruiting
Hospital Alvaro Cunqueiro
Coordinator of this site? Confirm its status
VigoSpainRecruiting
Hospital Universitario de Araba
Coordinator of this site? Confirm its status
Vitoria-GasteizSpainRecruiting
Hôpital Saint-André
Coordinator of this site? Confirm its status
BordeauxFranceCompleted
Le Centre Hospitalier Universitaire de Brest (CHRU Brest)
Coordinator of this site? Confirm its status
BrestFranceRecruiting
Le Centre Hospitalier Universitaire de Caen (CHRU Caen)
Coordinator of this site? Confirm its status
CaenFranceRecruiting
Le Centre Hospitalier Universitaire de Tours (CHRU Tours)
Coordinator of this site? Confirm its status
Chambray-lès-ToursFranceActive, not recruiting
Hopital Gabriel Montpied
Coordinator of this site? Confirm its status
Clermont-FerrandFranceRecruiting
Hopital Haut-Leveque - Chu
Coordinator of this site? Confirm its status
PessacFranceRecruiting
Hopitaux Universitaires de Strasbourg
Coordinator of this site? Confirm its status
StrasbourgFranceRecruiting
Ospedale Civile Ferrari
Coordinator of this site? Confirm its status
CastrovillariItalyRecruiting
Ospedale Maria Vittoria
Coordinator of this site? Confirm its status
TorinoItalyRecruiting
Pauls Stradins Clinical University Hospital
Coordinator of this site? Confirm its status
RigaLatviaRecruiting
Unidade Local De Saude Do Alto Ave E.P.E.
Coordinator of this site? Confirm its status
GuimaraesPortugalRecruiting
Unidade Local De Saude De Santa Maria E.P.E.
Coordinator of this site? Confirm its status
LisbonPortugalRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.