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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03850327




Registration number
NCT03850327
Ethics application status
Date submitted
11/02/2019
Date registered
21/02/2019
Date last updated
27/05/2021

Titles & IDs
Public title
BIO|CONCEPT.BIOMONITOR III
Scientific title
BIO|CONCEPT.BIOMONITOR III
Secondary ID [1] 0 0
RD020
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Syncope 0 0
Tachyarrhythmia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - BIOMONITOR III

Experimental: BIOMONITOR III -


Treatment: Devices: BIOMONITOR III
Patients with ICM indication receive a third-generation implantable cardiac monitor
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
1 month
Primary outcome [2] 0 0
R-wave amplitude
Timepoint [2] 0 0
1 month
Secondary outcome [1] 0 0
Insertion procedure of the BIOMONITOR III by using the incision and insertion tools
Timepoint [1] 0 0
At the day of insertion of the BIOMONITOR III

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Diagnosis
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/10/2019
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
HeartCare Partners - Wesley Testing - Auchenflower
Recruitment hospital [2] 0 0
Bundaberg Cardiology - Bundaberg
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
HeartCare Victoria - Doncaster - Balwyn
Recruitment hospital [5] 0 0
Mount Hospital - Perth
Recruitment hospital [6] 0 0
The Canberra Hospital - Canberra
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
4670 - Bundaberg
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3103 - Balwyn
Recruitment postcode(s) [5] 0 0
6000 - Perth
Recruitment postcode(s) [6] 0 0
2605 - Canberra
Recruitment postcode(s) [7] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biotronik SE & Co. KG
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03850327
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Olivier van den Brink, Dr.
Address 0 0
The Alfred Hospital, Melbourne, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03850327