BIO|CONCEPT.BIOMONITOR III

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03850327

Enrollment

Registered

2019-02-21

Start date

2019-03-08

Completion date

2019-10-06

Last updated

2021-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Syncope, Tachyarrhythmia

Keywords

Implantable Cardiac Monitor

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.

Interventions

DEVICEBIOMONITOR III

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Adverse Events	1 month	(procedure / device related)
R-wave amplitude	1 month	—

Secondary

Measure	Time frame	Description
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.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026