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NCT Number: NCT04075084

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.

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Key information

Conditions

Tachycardia Arrhythmias, Cardiac Atrial Fibrillation Bradycardia Brain Diseases Cardiac Conduction System Disease Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Consciousness Disorders Cryptogenic Stroke Heart Diseases Ischemic Stroke Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Syncope Unconsciousness Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Integral Health, Adelaide, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dörte Vossmeyer, Dr.

CONTACT

[email protected]

+49 30 68905 ext. 1306

Sabrina Hoche, Dr.

CONTACT

[email protected]

+49 30 68905 ext. 1337

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

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

Acronym: BIOSTREAM-ICM

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Aug 30, 2019
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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