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Trial registered on ANZCTR


Registration number
ACTRN12618001950257p
Ethics application status
Submitted, not yet approved
Date submitted
13/11/2018
Date registered
30/11/2018
Date last updated
30/11/2018
Date data sharing statement initially provided
30/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of a new implantable cardiac event recorder (BioMonitor III) in patients with suspected cardiac arrhythmias
Scientific title
Implantation and signal assessment of BioMonitor III in patients with suspected arrhythmias or symptoms suggestive of arrhythmic causes
Secondary ID [1] 296582 0
nil
Universal Trial Number (UTN)
Trial acronym
BIOMONITOR III First in Man (FIM) study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac arrhythmias 310389 0
Condition category
Condition code
Cardiovascular 309109 309109 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Implantation of an implantable cardiac monitor (ICM) subcutaneuously on the left side of the patient's chest/pectoral area. The device itself measures 7.5cm and is itself sterile and located inside the insertion tool. The biomonitor consists of a solid housing made of biocompatible titanium coated in silicone and a flexible silicone lead body. The implantation procedure takes less than one minute and will be performed by a medical doctor on the study. In brief, the procedure is as follows. An incision is made in the skin, whereupon the insertion tool is positioned at the specific location, and the pre-mounted biomonitor is released subcutaneuosly in the left pectoral region. The device remains implanted until sufficient information has been gathered for the doctor to diagnose the cardiac arrhythmia or until the battery runs out after about four years. The device automatically records a number of subcutaneous ECG episodes based on a number of cardiac rhythm related triggers (AF, VT, bradycardia etc). The patient can also prompt a recording by the device when experiencing a syncopal episode using a patient activator device which is supplied.
Intervention code [1] 312897 0
Diagnosis / Prognosis
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308095 0
Assessment of insertion success rate using a new insertion tool + incision tool. Success will be determined based on physicians ease of use of tools, duration of procedure, and a follow up assessment of any adverse events which may be associated with the insertion procedure.

This is a composite primary outcome which will be assessed by study specific questionnaires and also by examining the medical records around the procedure.

Possible adverse events like insertion site discomfort will be assessed by following the patient up over a month and examining their medical records.
Timepoint [1] 308095 0
Implant and 1 month after insertion
Primary outcome [2] 308096 0
Assessment of R-wave amplitude. This will be done via a device programmer which is able to detect these parameters via telemetry. The device programmer is called Renamic and is used as standard of care in cardiac re-synchronization therapy by BIOTRONIK. The information can also be gleaned via wireless remote monitoring.
Timepoint [2] 308096 0
Implant, 1 week and 1 month after insertion
Secondary outcome [1] 353931 0
Assess the sensing quality of the BIOMONITOR III. This will be done via a device programmer which is able to detect these parameters via telemetry. The device programmer is called Renamic and is used as standard of care in cardiac re-synchronization therapy by BIOTRONIK. The information can also be gleaned via wireless remote monitoring.
Timepoint [1] 353931 0
1 month after implant

Eligibility
Key inclusion criteria
1. Patient is at high risk of developing a clinically important cardiac arrhythmia; or
2. Patient is undergoing investigation for symptoms such as palpitations, pre-syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or
3. Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or
4. Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure.
5. Patient is able to understand the nature of study and has provided written informed consent
6. Patient is willing and able to perform all follow up visits at the study site
7. Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients implanted with ICD or pacemaker.
2. Patient is pregnant or breast feeding.
3. Patient is less than 18 years old.
4. Patient is participating in another interventional clinical investigation
5. Patient´s life-expectancy is less than 6 months.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 12397 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 12398 0
The Canberra Hospital - Garran
Recruitment hospital [3] 12399 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [4] 12400 0
Bundaberg Hospital - Bundaberg
Recruitment hospital [5] 12401 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 12402 0
The Wesley Hospital - Auchenflower
Recruitment hospital [7] 12403 0
The Alfred - Prahran
Recruitment hospital [8] 12404 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [9] 12405 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [10] 12406 0
St Andrew's - Ipswich Private Hospital - Ipswich
Recruitment hospital [11] 12407 0
Warringal Private Hospital - Heidelberg
Recruitment postcode(s) [1] 24664 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 24665 0
2605 - Garran
Recruitment postcode(s) [3] 24666 0
2076 - Wahroonga
Recruitment postcode(s) [4] 24667 0
4670 - Bundaberg
Recruitment postcode(s) [5] 24668 0
5000 - Adelaide
Recruitment postcode(s) [6] 24669 0
4066 - Auchenflower
Recruitment postcode(s) [7] 24670 0
3004 - Prahran
Recruitment postcode(s) [8] 24671 0
3168 - Clayton
Recruitment postcode(s) [9] 24672 0
2010 - Darlinghurst
Recruitment postcode(s) [10] 24673 0
4305 - Ipswich
Recruitment postcode(s) [11] 24674 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 301162 0
Commercial sector/Industry
Name [1] 301162 0
BIOTRONIK Australia Pty. Ltd.
Address [1] 301162 0
Level 4, Building 2
20 Bridge St
Pymble NSW 2073
Country [1] 301162 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
BIOTRONIK Australia Pty. Ltd.
Address
Level 4, Building 2
20 Bridge St
Pymble NSW 2073
Country
Australia
Secondary sponsor category [1] 300783 0
None
Name [1] 300783 0
Address [1] 300783 0
Country [1] 300783 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301907 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 301907 0
Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 301907 0
Australia
Date submitted for ethics approval [1] 301907 0
15/11/2018
Approval date [1] 301907 0
Ethics approval number [1] 301907 0

Summary
Brief summary
BIOMONITOR III First In Man Study aims to collect first implantation experience with a new generation of implantable cardiac monitors. BIOMONITOR III is a miniaturised version of its predecessor BIOMONITOR II which has sought to address the issue of increasing patient comfort with a smaller device, but still having all of the same diagnostic capability as BIOMONITOR II. The objective thus is to examine the ease of implant of the device by physicians, and to assess its full diagnostic capacity on patients.
Trial website
none
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 88514 0
Dr Justin Mariani
Address 88514 0
The Alfred Hospital
Cardiology Department,
55 Commercial Rd
Melbourne, 3004
Country 88514 0
Australia
Phone 88514 0
+61 3 9076 3270
Fax 88514 0
Email 88514 0
justin.mariani@svhm.org.au
Contact person for public queries
Name 88515 0
Mr Falko Thiele
Address 88515 0
BIOTRONIK Australia Pty. Ltd.
Level 4, Building 2
20 Bridge St
Pymble NSW 2073
Country 88515 0
Australia
Phone 88515 0
+61 2 9497 3719
Fax 88515 0
Email 88515 0
Falko.Thiele@biotronik.com
Contact person for scientific queries
Name 88516 0
Mr Falko Thiele
Address 88516 0
BIOTRONIK Australia Pty. Ltd.
Level 4, Building 2
20 Bridge St
Pymble NSW 2073
Country 88516 0
Australia
Phone 88516 0
+61 2 9497 3719
Fax 88516 0
Email 88516 0
Falko.Thiele@biotronik.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
Summary results
No Results