Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001266651
Ethics application status
Approved
Date submitted
19/11/2014
Date registered
3/12/2014
Date last updated
22/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of a new implantable cardiac event recorder (BioMonitor 2) in patients with suspected cardiac arrhythmias
Scientific title
Implantation and signal assessment of BioMonitor 2 in patients with suspected arrhythmias or symptoms suggestive of arrhythmic causes
Secondary ID [1] 285703 0
nil
Universal Trial Number (UTN)
Trial acronym
BioMonitor 2 Pilot Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac arrhythmias 293563 0
Condition category
Condition code
Cardiovascular 293849 293849 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Implantation of an implantable cardiac event recorder in the patients chest just under the skin. The implantation procedure takes less than one minute. 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 using a patient activator device which is supplied.
Intervention code [1] 290646 0
Diagnosis / Prognosis
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293629 0
R-wave amplitude of BioMonitor 2 >= 0.3 mV as measured with an external programming device during the scheduled follow-up visit
Timepoint [1] 293629 0
1 week follow-up visit
Secondary outcome [1] 311491 0
Assessment of implantation tool set handling by qualitative evaluation by the implanter
Timepoint [1] 311491 0
Implantation

Eligibility
Key inclusion criteria
Patient at high risk of developing a clinically important cardiac arrhythmia or undergoing investigation for symptoms suggestive of cardiac arrhythmias or detection of paroxysmal atrial fibrillation following cryptogenic stroke or patients undergoing or having undergone AF ablation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients implanted with ICD or pacemaker
Patient who is pregnant or breast-feeding
Life expectancy of 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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For continuous variables descriptive statistics mean, standard deviation and quartiles will be calculated. For nominal or ordinal variables frequencies and proportions will be calculated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/12/2014
Actual
18/12/2014
Date of last participant enrolment
Anticipated
22/04/2015
Actual
6/07/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment hospital [1] 3159 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 3160 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [3] 3161 0
Hollywood Private Hospital - Nedlands
Recruitment hospital [4] 3162 0
Joondalup Health Campus - Joondalup
Recruitment hospital [5] 3163 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 8948 0
2031 - Randwick
Recruitment postcode(s) [2] 8949 0
2076 - Wahroonga
Recruitment postcode(s) [3] 8950 0
6009 - Nedlands
Recruitment postcode(s) [4] 8951 0
6027 - Joondalup
Recruitment postcode(s) [5] 8952 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 290275 0
Commercial sector/Industry
Name [1] 290275 0
BIOTRONIK Australia Pty. Ltd.
Country [1] 290275 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] 288985 0
None
Name [1] 288985 0
Address [1] 288985 0
Country [1] 288985 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291973 0
South Eastern Sydney Local Health District Ethics Committee
Ethics committee address [1] 291973 0
Research Support Office
G71, East Wing
Edmund Blacket Building
Prince of Wales Hospital
Barker St
Randwick NSW 2031
Ethics committee country [1] 291973 0
Australia
Date submitted for ethics approval [1] 291973 0
04/11/2014
Approval date [1] 291973 0
19/12/2014
Ethics approval number [1] 291973 0
HREC ref. no. 14/281 (HREC/14/POWH/626)

Summary
Brief summary
BioMonitor 2 Pilot Study aims to collect first implantation experience with a new generation of implantable cardiac event recorder.
Trial website
none
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 52906 0
Dr Sze-Yuan Ooi
Address 52906 0
Prince of Wales Hospital
Eastern Heart Clinic
Barker St
Randwick NSW 2031
Country 52906 0
Australia
Phone 52906 0
+61 2 9382 0770
Fax 52906 0
Email 52906 0
[email protected]
Contact person for public queries
Name 52907 0
Mr Falko Thiele
Address 52907 0
BIOTRONIK Australia Pty. Ltd.
Level 4, Building 2
20 Bridge St
Pymble NSW 2073
Country 52907 0
Australia
Phone 52907 0
+61 2 9497 3719
Fax 52907 0
Email 52907 0
[email protected]
Contact person for scientific queries
Name 52908 0
Mr Falko Thiele
Address 52908 0
BIOTRONIK Australia Pty. Ltd.
Level 4, Building 2
20 Bridge St
Pymble NSW 2073
Country 52908 0
Australia
Phone 52908 0
+61 2 9497 3719
Fax 52908 0
Email 52908 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBioMonitor 2 Pilot Study: Early Experience With Implantation of the Biotronik BioMonitor 2 Implantable Cardiac Monitor.2018https://dx.doi.org/10.1016/j.hlc.2017.09.005
N.B. These documents automatically identified may not have been verified by the study sponsor.