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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04025710




Registration number
NCT04025710
Ethics application status
Date submitted
17/07/2019
Date registered
19/07/2019
Date last updated
27/11/2024

Titles & IDs
Public title
Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
Scientific title
BIO|MASTER.BIOMONITOR III
Secondary ID [1] 0 0
BA109
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Other: all patients -


Treatment: Devices: BIOMONITOR III and BIOMONITOR IIIm
* Insertion of BIOMONITOR III or BIOMONITOR IIIm
* three scheduled in-office follow-ups
* 48-hour Holter ECG
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
SADE-free Rate Until the 3-month Follow-up
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
R-wave Amplitude
Timepoint [1] 0 0
10 days to 4 weeks after insertion; 3-months
Secondary outcome [2] 0 0
Noise Burden
Timepoint [2] 0 0
10 days to 4 weeks after insertion; 3-months
Secondary outcome [3] 0 0
Assessment of P-wave Visibility
Timepoint [3] 0 0
10 days to 4 weeks after insertion; 3-months
Secondary outcome [4] 0 0
SADE-free Rate Until the 12-month Follow-up
Timepoint [4] 0 0
12-months

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 the study and able to provide written informed consent.
* Patient is willing and able to perform all follow-up visits at the investigational site.
* Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient is implanted with an ICD or pacemaker.
* Patient is pregnant or breast-feeding.
* Patient is less than 18 years old.
* Patient's life-expectancy is less than 12 months.
* Patient is participating in another interventional clinical investigation.

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
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
17/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/04/2022
Sample size
Target
Accrual to date
Final
167
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
GenesisCare Wesley - Auchenflower
Recruitment hospital [2] 0 0
GenesisCare Bundaberg - Bundaberg
Recruitment hospital [3] 0 0
GenesisCare Doncaster - Doncaster East
Recruitment hospital [4] 0 0
Canberra Heart Rhythm Clinic - Garran
Recruitment hospital [5] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Auchenflower
Recruitment postcode(s) [2] 0 0
- Bundaberg
Recruitment postcode(s) [3] 0 0
- Doncaster East
Recruitment postcode(s) [4] 0 0
- Garran
Recruitment postcode(s) [5] 0 0
- Randwick
Recruitment postcode(s) [6] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Austria
State/province [2] 0 0
Wels
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Denmark
State/province [4] 0 0
Viborg
Country [5] 0 0
Germany
State/province [5] 0 0
Bad Neustadt An Der Saale
Country [6] 0 0
Germany
State/province [6] 0 0
Bad Oeynhausen
Country [7] 0 0
Germany
State/province [7] 0 0
Dresden
Country [8] 0 0
Germany
State/province [8] 0 0
Gera
Country [9] 0 0
Germany
State/province [9] 0 0
Giessen
Country [10] 0 0
Germany
State/province [10] 0 0
Greifswald
Country [11] 0 0
Germany
State/province [11] 0 0
Leipzig
Country [12] 0 0
Germany
State/province [12] 0 0
Leverkusen
Country [13] 0 0
Germany
State/province [13] 0 0
Lünen
Country [14] 0 0
Germany
State/province [14] 0 0
Minden
Country [15] 0 0
Spain
State/province [15] 0 0
León
Country [16] 0 0
Spain
State/province [16] 0 0
Ourense
Country [17] 0 0
Spain
State/province [17] 0 0
Santander
Country [18] 0 0
Switzerland
State/province [18] 0 0
Lausanne
Country [19] 0 0
Switzerland
State/province [19] 0 0
Lugano
Country [20] 0 0
Switzerland
State/province [20] 0 0
Saint Gallen

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the BIOMONITOR III and BIOMONITOR IIIm that are discovered or remain even after risk analysis, risk mitigation and successful conformity assessment. Furthermore, this study will also provide additional data as required by regulatory authorities outside of the CE-region.
Trial website
https://clinicaltrials.gov/study/NCT04025710
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Deneke, Prof. Dr.
Address 0 0
RHÖN-KLINIKUM Campus Bad Neustadt, Germany
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/study/NCT04025710