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

September 26, 2025 updated by: Biotronik SE & Co. KG

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Adelaide, Australia
        • Recruiting
        • Integral Health
        • Contact:
          • Dennis Lau, Dr.
      • Adelaide, Australia
        • Completed
        • Royal Adelaide Hospital
  • Czechia
      • České Budějovice, Czechia, 37001
        • Recruiting
        • Nemocnice Ceske Budejovice, a.s.
        • Contact:
          • Alan Bulava, Prof.
  • France
      • Bordeaux, France
        • Completed
        • Hôpital Saint-André
      • Brest, France
        • Recruiting
        • Le Centre Hospitalier Universitaire de Brest (CHRU Brest)
        • Contact:
          • Jacques Mansourati, Pr.
      • Caen, France
        • Recruiting
        • Le Centre Hospitalier Universitaire de Caen (CHRU Caen)
        • Contact:
          • Virgine Ferchaud, Dr
      • Chambray-lès-Tours, France
        • Active, not recruiting
        • Le Centre Hospitalier Universitaire de Tours (CHRU Tours)
      • Clermont-Ferrand, France
        • Recruiting
        • Hôpital Gabriel Montpied
        • Contact:
          • Romain Eschalier, Pr.
      • Pessac, France
        • Recruiting
        • Hôpital Haut Lévêque (CHU)
        • Contact:
          • Sylvain Ploux, Pr.
      • Strasbourg, France
        • Recruiting
        • Hôpitaux Universitaires de Strasbourg
        • Contact:
          • Laurence Jesel-Morel, Dr.
  • Germany
      • Ahaus, Germany
        • Recruiting
        • St. Marienkrankhaus Klinikum Westmünsterland GmbH
        • Contact:
          • Alessandro Cueno, Dr.
      • Bad Nauheim, Germany
        • Recruiting
        • Kerckhoff-Klinik GmbH
        • Contact:
          • Andreas Hain, Dr.
      • Bad Neustadt an der Saale, Germany
        • Active, not recruiting
        • Rhön-Klinikum
      • Dresden, Germany
        • Completed
        • Universitätsklinik an der Technischen Universität Dresden
      • Erfurt, Germany
        • Recruiting
        • HELIOS Klinikum Erfurt
        • Contact:
          • Frank Steinborn, Dr.
      • Herford, Germany
        • Recruiting
        • Klinikum Herford
        • Contact:
          • Jan Kähler, Prof. Dr.
      • Leipzig, Germany
        • Recruiting
        • Helios Health Institute GmbH
        • Contact:
          • Sotirios Nedios, Dr.
      • Mitte, Germany
        • Recruiting
        • Deutsches Herzzentrum der Charité
        • Contact:
          • Verena Tscholl, Dr.
      • München, Germany
        • Active, not recruiting
        • Klinikum rechts der Isar der Technischen Universität München
      • Steglitz, Germany
        • Recruiting
        • Deutsches Herzzentrum der Charité
        • Contact:
          • Patrick Nagel, Dr.
  • Italy
      • Castrovillari, Italy
        • Recruiting
        • Ospedale Civile Ferrari
        • Contact:
          • Giovanni Bisignani, Dr.
      • Torino, Italy
        • Recruiting
        • Ospedale Maria Vittoria
        • Contact:
          • Massimo Giammaria, Dr.
  • Latvia
      • Riga, Latvia, 1002
        • Recruiting
        • Pauls Stradins Clinical University Hospital
        • Contact:
          • Andrejs Erglis, Prof
  • Portugal
      • Guimarães, Portugal
        • Recruiting
        • Unidade Local de Saúde do Alto Ave, E. P. E.
        • Contact:
          • Victor M. Sanfins, Dr.
      • Lisbon, Portugal
        • Recruiting
        • Unidade Local de Saúde de Santa Maria, E. P. E.
        • Contact:
          • João de Sousa, Dr.
  • Spain
      • Erandio, Spain
        • Recruiting
        • Centro Médico Teknon
        • Contact:
          • Antonio Berruezo Sanchez, Dr.
      • Fuenlabrada, Spain
        • Active, not recruiting
        • Hospital De Fuenlabrada
      • Vigo, Spain
        • Recruiting
        • Hospital Alvaro Cunqueiro
        • Contact:
          • Pilar Cabanas, Dr.
      • Vitoria-Gasteiz, Spain
        • Recruiting
        • Hospital Universitario de Araba
        • Contact:
          • Enrique Garcia, Dr.
  • Switzerland
      • Wetzikon, Switzerland
        • Completed
        • GZO Spital Wetzikon
      • Zurich, Switzerland
        • Recruiting
        • Universitätsspital Zürich (USZ)
        • Contact:
          • Daniel Hofer, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The intended patient population consists of all patients who would benefit from long-term cardiac rhythm monitoring.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to diagnosis
Time Frame: 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.
The time to a relevant diagnosis can vary significantly. The time period starts with the insertion of the device.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insertion procedure and success
Time Frame: Data on BIOMONITOR insertion procedure and success rate are collected at day of insertion.
Information on the insertion procedure (Operation time, handling of the BIOMONITOR incl. incision and insertion tool); Success rate of insertions.
Data on BIOMONITOR insertion procedure and success rate are collected at day of insertion.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensing and noise
Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Quality of sensing Amplitude (Millivolt) and electrical noise (%) detected by the BIOMONITOR.
Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Inspection results of the insertion site
Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Rating of wound healing and cosmetic outcome by the physician/patient (5-level scale).
Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Device migration
Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Assessement whether the BIOMONITOR migrates under the skin.
Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Diagnosis and clinical actions after arrhythmia detection
Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Documentation whether the BIOMONITOR helps to detect arrhythmias. Documentation of therapies used to treat these arrhythmias and whether the BIOMONITOR helps to monitor therapy success.
Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Explantation / deactivation / exchange information of the BIOMONITOR
Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Collect information about explantation, deactivation and exchanges of the BIOMONITOR, such as number, reason, and data on procedure.
Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Adverse Events
Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Collect and analyze adverse events.
Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Device Deficiencies
Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Collect and analyze device deficiencies. Calculate rate (frequency) of device deficiencies.
Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Documentation of imaging techniques, if applied.
Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Documentation if patients underwent any MRI examinations or mammography. Documentation of exact kind of examination and occurrences with regard to the BIOMONITOR.
Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Patient contentment regarding BIOMONITOR wearability
Time Frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Patients opinion about the wearing comfort (5-level-scale).
Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2019

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

August 8, 2019

First Submitted That Met QC Criteria

August 28, 2019

First Posted (Actual)

August 30, 2019

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS061

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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