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Taking people in SpainNo phase

Observes routine care of patients with heart rhythm monitors

Follows people with heart rhythm problems who wear an implanted cardiac monitor.

Plain-language title generated from the registry record
Registry title: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

Key facts

Where
Erandio, Fuenlabrada, Vigo, and Vitoria-Gasteiz, SpainSee the 4 sites

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The registry is looking for adults who are going to receive a BIOTRONIK implantable cardiac monitor (ICM) and who can use the CardioMessenger and BIOTRONIK Home Monitoring.

Age
18 years or older
Sex
Women and men can join

Main reasons for not taking part

  • Pregnant or breast feeding
  • Younger than 18 years
  • Taking part in another interventional clinical investigation (the submodules of BIO|STREAM.ICM are the exception)

Read by machine on 12 November 2026.

Where in Spain

  • Centro Médico TeknonErandio, SpainContact: Antonio Berruezo Sanchez, Dr.Taking people
  • Hospital de FuenlabradaFuenlabrada, SpainContact: Sabrina Hoche, Dr.No longer taking part
  • Hospital Alvaro CunqueiroVigo, SpainContact: Pilar Cabanas, Dr.Taking people
  • Hospital Universitario de ArabaVitoria-Gasteiz, SpainContact: Enrique Garcia, Dr.Taking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Biotronik SE & Co. KG
Trial code
NCT04075084
Record updated
1 October 2025
Original description
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.Read full original descriptionShow less

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

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.

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

ClinicalTrials.gov NCT04075084