BIO|CONCEPT.BIOMONITOR III

Atrial Fibrillation Clinical Trial

Official title:

BIO|CONCEPT.BIOMONITOR III

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03850327
• Other study ID #: RD020
• Status: Completed
• Phase: N/A
• Start date: March 8, 2019
• Est. completion date: October 6, 2019

Study information

• Verified date: December 2018
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 6, 2019
• Est. primary completion date: October 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Syncope
• Tachyarrhythmia
• Tachycardia

Intervention

Device:
• BIOMONITOR III
Patients with ICM indication receive a third-generation implantable cardiac monitor

Locations

Country	Name	City	State
Australia	HeartCare Partners - Wesley Testing	Auchenflower	Queensland
Australia	HeartCare Victoria - Doncaster	Balwyn	Victoria
Australia	Bundaberg Cardiology	Bundaberg	Queensland
Australia	The Canberra Hospital	Canberra
Australia	The Alfred Hospital	Melbourne
Australia	Mount Hospital	Perth	Western Australia
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	(procedure / device related)	1 month
Primary	R-wave amplitude		1 month
Secondary	Insertion procedure of the BIOMONITOR III by using the incision and insertion tools	Assessment of insertion procedure by using a questionaire about handling and time record.	At the day of insertion of the BIOMONITOR III