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Completed

NCT Number: NCT04025710

Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)

This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the BIOMONITOR III and BIOMONITOR IIIm that are discovered or remain even after risk analysis, risk mitigation and successful conformity assessment. Furthermore, this study will also provide additional data as required by regulatory authorities outside of the CE-region.

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Key information

Conditions

Tachyarrhythmia Arrhythmias, Cardiac Atrial Fibrillation Atrial Fibrillation (AF) 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 Tachycardia Unconsciousness Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GenesisCare Wesley, Auchenflower, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is at high risk of developing a clinically important cardiac arrhythmia; or
  • Patient is undergoing investigation for symptoms such as palpitations, pre- syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or
  • Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or
  • Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure.
  • Patient is able to understand the nature of the study and able to provide written informed consent.
  • Patient is willing and able to perform all follow-up visits at the investigational site.
  • Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.

Exclusion criteria

  • Patient is implanted with an ICD or pacemaker.
  • Patient is pregnant or breast-feeding.
  • Patient is less than 18 years old.
  • Patient's life-expectancy is less than 12 months.
  • Patient is participating in another interventional clinical investigation.

Treatment and study plan

BIOMONITOR III and BIOMONITOR IIIm

Device
  • Insertion of BIOMONITOR III or BIOMONITOR IIIm
  • three scheduled in-office follow-ups
  • 48-hour Holter ECG

Primary outcomes

  1. SADE-free Rate Until the 3-month Follow-up

    Time frame: 3 months

    SADE-free rate related to BIOMONITOR III and BIOMONITOR IIIm including incision and insertion tool set until 3-month follow-up

Secondary outcomes

  1. R-wave Amplitude

    Time frame: 10 days to 4 weeks after insertion; 3-months

    The secondary endpoint 1 evaluates the R-wave amplitude at the 1st follow-up and at 3-month follow-up by measuring both, the lowest and the highest amplitude value via the programmer.

  2. Noise Burden

    Time frame: 10 days to 4 weeks after insertion; 3-months

    The secondary endpoint 2 evaluates the noise burden at the 1st follow-up and at 3-month follow-up by retrieving the percentage of noise via the programmer.

  3. Assessment of P-wave Visibility

    Time frame: 10 days to 4 weeks after insertion; 3-months

    The secondary endpoint 3 evaluates the P-wave visibility at 1st, 3- and 12-month follow-up. The investigator will evaluate whether P-waves can be recognized in the stored sECGs showing sinus rhythm. The number of heart cycles and observed P-waves which can undoubtly be identified in ECGs will be assessed by the investigator.

  4. SADE-free Rate Until the 12-month Follow-up

    Time frame: 12-months

    The secondary endpoint 4 is the SADE-free rate related to the BIOMONITOR III and BIOMONITOR IIIm 12 months after insertion.

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

BIO|MASTER.BIOMONITOR III

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 19, 2019
Registry last updated
Nov 27, 2024

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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