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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/NCT04025710
Registration number
NCT04025710
Ethics application status
Date submitted
17/07/2019
Date registered
19/07/2019
Date last updated
11/01/2024
Titles & IDs
Public title
Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
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Scientific title
BIO|MASTER.BIOMONITOR III
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Secondary ID [1]
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BA109
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Tachyarrhythmia
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Atrial Fibrillation (AF)
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Syncope
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Cryptogenic Stroke
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Condition category
Condition code
Stroke
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Ischaemic
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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SADE-free Rate Until the 3-month Follow-up
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Assessment method [1]
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SADE-free rate related to BIOMONITOR III and BIOMONITOR IIIm including incision and insertion tool set until 3-month follow-up
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Timepoint [1]
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3 months
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Secondary outcome [1]
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R-wave Amplitude
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Assessment method [1]
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The secondary endpoint 1 evaluates the R-wave amplitude at the 1st follow-up and at 3-month follow-up by measuring both, the lowest and the highest amplitude value via the programmer.
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Timepoint [1]
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10 days to 4 weeks after insertion; 3-months
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Secondary outcome [2]
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Noise Burden
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Assessment method [2]
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The secondary endpoint 2 evaluates the noise burden at the 1st follow-up and at 3-month follow-up by retrieving the percentage of noise via the programmer.
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Timepoint [2]
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10 days to 4 weeks after insertion; 3-months
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Secondary outcome [3]
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Assessment of P-wave Visibility
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Assessment method [3]
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The secondary endpoint 3 evaluates the P-wave visibility at 1st, 3- and 12-month follow-up. The investigator will evaluate whether P-waves can be recognized in the stored sECGs showing sinus rhythm. The number of heart cycles and observed P-waves which can undoubtly be identified in ECGs will be assessed by the investigator.
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Timepoint [3]
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10 days to 4 weeks after insertion; 3-months
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Secondary outcome [4]
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SADE-free Rate Until the 12-month Follow-up
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Assessment method [4]
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The secondary endpoint 4 is the SADE-free rate related to the BIOMONITOR III and BIOMONITOR IIIm 12 months after insertion.
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Timepoint [4]
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12-months
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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.
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Other
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/10/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/04/2022
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Sample size
Target
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Accrual to date
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Final
167
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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GenesisCare Wesley - Auchenflower
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Recruitment hospital [2]
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GenesisCare Bundaberg - Bundaberg
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Recruitment hospital [3]
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GenesisCare Doncaster - Doncaster East
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Recruitment hospital [4]
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Canberra Heart Rhythm Clinic - Garran
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Recruitment hospital [5]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [6]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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- Auchenflower
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Recruitment postcode(s) [2]
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- Bundaberg
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Recruitment postcode(s) [3]
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- Doncaster East
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Recruitment postcode(s) [4]
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- Garran
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Recruitment postcode(s) [5]
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- Randwick
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Recruitment postcode(s) [6]
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- Woolloongabba
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Linz
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Country [2]
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Austria
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State/province [2]
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Wels
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Country [3]
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Austria
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State/province [3]
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Wien
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Country [4]
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Denmark
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State/province [4]
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Viborg
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Country [5]
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Germany
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State/province [5]
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Bad Neustadt An Der Saale
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Country [6]
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Germany
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State/province [6]
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Bad Oeynhausen
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Country [7]
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Germany
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State/province [7]
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Dresden
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Country [8]
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Germany
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State/province [8]
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Gera
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Country [9]
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Germany
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State/province [9]
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Giessen
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Country [10]
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Germany
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State/province [10]
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Greifswald
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Country [11]
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Germany
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State/province [11]
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Leipzig
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Country [12]
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Germany
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State/province [12]
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Leverkusen
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Country [13]
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Germany
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State/province [13]
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Lünen
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Country [14]
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Germany
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State/province [14]
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Minden
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Country [15]
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Spain
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State/province [15]
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León
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Country [16]
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Spain
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State/province [16]
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Ourense
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Country [17]
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Spain
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State/province [17]
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Santander
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Country [18]
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Switzerland
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State/province [18]
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Lausanne
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Country [19]
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Switzerland
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State/province [19]
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Lugano
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Country [20]
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Switzerland
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State/province [20]
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Saint Gallen
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Biotronik SE & Co. KG
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04025710
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Thomas Deneke, Prof. Dr.
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Address
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RHÖN-KLINIKUM Campus Bad Neustadt, Germany
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04025710
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