BIO|CONCEPT.BIOMONITOR III

The objective of the study is to confirm the safety and efficacy of the BIOMONITOR III system. Furthermore, the insertion procedure, the use and handling of the incision and insertion tools and the sensing quality of the BIOMONITOR III will be assessed.

Completed

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Consciousness Disorders Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Syncope Tachyarrhythmia Tachycardia Unconsciousness

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HeartCare Partners - Wesley Testing, Auchenflower, Queensland, Australia

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 study and has provided written informed consent.
Patient is willing and able to perform all follow up visits at the study site.
Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.

Exclusion criteria

Patients implanted with ICD or pacemaker.
Patient is pregnant or breast feeding.
Patient is less than 18 years old.
Patient is participating in another interventional clinical investigation
Patient´s life-expectancy is less than 6 months.

Treatment and study plan

BIOMONITOR III

Device

Patients with ICM indication receive a third-generation implantable cardiac monitor

Primary outcomes

Adverse Events

Time frame: 1 month

(procedure / device related)
R-wave amplitude

Time frame: 1 month

Secondary outcomes

Insertion procedure of the BIOMONITOR III by using the incision and insertion tools

Time frame: At the day of insertion of the BIOMONITOR III

Assessment of insertion procedure by using a questionaire about handling and time record.

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Feb 21, 2019
Registry last updated: May 27, 2021

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.

Published trials that share one or more normalized conditions with this study.

Completed