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Completed

NCT Number: NCT04206774

BIO|STREAM.ICM France

The main objective of the BIO│STREAM.ICM France submodule is to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR system

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Key information

Conditions

Syncope Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Consciousness Disorders Cryptogenic Stroke Ischemic Stroke Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Unconsciousness Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Gabriel Montpied, Clermont-Ferrand, Caen, France

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About this study

The BIO|STREAM.ICM submodule will recruit a subset of patients with syncope with uncertain origin and cryptogenic stroke without history of atrial arrhythmia from the existing population enrolled in the BIO|STREAM.ICM registry. The submodule study is designed to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR System.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Indication for ICM device in accordance with the European guidelines: syncope with uncertain origin or cryptogenic stroke without history of atrial arrhythmia
  • Enrolled in the BIO|STREAM.ICM registry

Exclusion criteria

  • Life-expectancy is less than 3 months
  • Already implanted with BIOMONITOR

Treatment and study plan

Primary outcomes

  1. SADE free rate

    Time frame: 3 month

    Serious adverse device effect (SADE) free rate related to the BIOMONITOR system

Other outcomes

  1. R-wave amplitude

    Time frame: 3 month

    Assessment of R-wave Amplitude (Millivolt) detected by the BIOMONITOR and transmitted via Home Monitoring

  2. Noise burden

    Time frame: 3 month

    Assessment of electrical noise burden (%) detected by the BIOMONITOR and transmitted via Home Monitoring

  3. Ventricular rate

    Time frame: 3 month

    Assessment of mean ventricular rate (bpm) detected by the BIOMONITOR and transmitted via Home Monitoring

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

BIO|STREAM.ICM France, Submodule of the BIO|STREAM.ICM Registry

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2019
Registry last updated
Jan 4, 2022

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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