BIO|CONCEPT.BIOMONITOR III

Not Applicable

Completed

• Conditions: Syncope; Tachyarrhythmia; Atrial Fibrillation
• Interventions: Device: BIOMONITOR III

• Registration Number: NCT03850327
• Lead Sponsor: Biotronik SE & Co. KG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-21
• Study Start: 2019-03-08
• Primary Completion: 2019-10-06
• Study Completion: 2019-10-06
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BIOMONITOR III	BIOMONITOR III	-

Primary Outcome Measures

Name	Time	Method
Adverse Events	1 month	(procedure / device related)
R-wave amplitude	1 month

Secondary Outcome Measures

Name	Time	Method
Insertion procedure of the BIOMONITOR III by using the incision and insertion tools	At the day of insertion of the BIOMONITOR III	Assessment of insertion procedure by using a questionaire about handling and time record.

Trial Locations

Locations (7)

The Alfred Hospital; 🇦🇺 Melbourne, Australia

The Canberra Hospital; 🇦🇺 Canberra, Australia

Mount Hospital; 🇦🇺 Perth, Western Australia, Australia

HeartCare Partners - Wesley Testing; 🇦🇺 Auchenflower, Queensland, Australia

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

Bundaberg Cardiology; 🇦🇺 Bundaberg, Queensland, Australia

HeartCare Victoria - Doncaster; 🇦🇺 Balwyn, Victoria, Australia