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Observing patients with BIOTRONIK Implantable Cardiac Monitors

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

Observational Biotronik SE & Co. KG · NCT04075084

This study looks at how well the BIOMONITOR III and similar heart monitors work and keep patients safe over time.

Quick facts

Study typeObservational
Enrollment1400 (estimated)
Ages18 Years and up
SexAll
SponsorBiotronik SE & Co. KG Industry-sponsored
Locations31 sites (Adelaide and 30 other locations)
Trial IDNCT04075084 on ClinicalTrials.gov

What this trial studies

This registry aims to assess the long-term outcomes, performance, and safety of the BIOMONITOR III and its successors in a real-world clinical setting. It is designed to facilitate additional scientific and regulatory investigations while minimizing the burden on patients and investigational sites. The study will collect data on patients receiving these cardiac monitors to better understand their effectiveness and safety over time.

Who should consider this trial

Good fit: Ideal candidates include patients who are set to receive a BIOTRONIK Implantable Cardiac Monitor and can provide informed consent.

Not a fit: Patients who are pregnant, breastfeeding, under 18 years old, or participating in another interventional clinical investigation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the management and monitoring of patients with various cardiac conditions, leading to improved patient outcomes.

How similar studies have performed: Other studies involving implantable cardiac monitors have shown promising results, indicating that this approach is supported by previous research.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Adelaide and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions TachycardiaAtrial FibrillationSyncopeBradycardiaCryptogenic StrokeImplantable Cardiac MonitorBIOMONITOR IIIBIOMONITOR IV
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.