BIO|CONCEPT.BIOMONITOR III

NCT ID: NCT03850327

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-08
• Study Completion Date: 2019-10-06

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.

Conditions

Atrial Fibrillation; Syncope; Tachyarrhythmia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

BIOMONITOR III

Group Type: EXPERIMENTAL

BIOMONITOR III

Intervention Type: DEVICE

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

Interventions

BIOMONITOR III

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier van den Brink, Dr.

Role: PRINCIPAL_INVESTIGATOR

The Alfred Hospital, Melbourne, Australia

Locations

HeartCare Partners - Wesley Testing

Auchenflower, Queensland, Australia

Bundaberg Cardiology

Bundaberg, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

HeartCare Victoria - Doncaster

Balwyn, Victoria, Australia

Mount Hospital

Perth, Western Australia, Australia

The Canberra Hospital

Canberra, , Australia

The Alfred Hospital

Melbourne, , Australia

Countries

Australia

Other Identifiers

RD020

Identifier Type: -

Identifier Source: org_study_id