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Trial registered on ANZCTR


Registration number
ACTRN12618001359224
Ethics application status
Approved
Date submitted
2/07/2018
Date registered
13/08/2018
Date last updated
30/10/2018
Date data sharing statement initially provided
30/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Remote Monitoring impact on cardiac arrhythmia detection in Adults with Implantable Loop Recorders
Scientific title
A Randomised, Controlled Trial of Remote Monitoring versus office-based follow-up for cardiac arrhythmia detection in Adults with Implantable Loop Recorders.
Secondary ID [1] 295282 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Syncope. 308459 0
Embolic stroke. 309213 0
Condition category
Condition code
Cardiovascular 307442 307442 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 307443 307443 0 0
Other cardiovascular diseases
Stroke 307924 307924 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Remote monitors will be provided for use with implantable loop recorders (already implanted separate to this study) for participants to keep at home. A remote monitoring service will be provided with one phone call at 6 weeks after commencement (to confirm there are no issues with the operation of the home monitor, and to address any queries regarding its use), and no office visits required. Any transmitted events will be acted on within the next business day. The trial monitoring period will be for 12 months. For any significant symptoms or events (such as syncope or severe pre-sycnope), participants may notify and have an additional device check done or attend for an office/hospital visit at the time.
Intervention code [1] 301614 0
Diagnosis / Prognosis
Comparator / control treatment
Followup for implantable loop recorders with office visits for device checking at standard intervals of 6 weeks, 6, and 12 months after implantation. For any significant symptoms or events, participants may notify and have a device check done or attend for an office/hospital visit at the time.
Control group
Active

Outcomes
Primary outcome [1] 306408 0
Time to first hospital admission, as reported by participants and assessed at final follow-up visit at 12 months.
Timepoint [1] 306408 0
End of follow-up of 12 months after randomisation.
Primary outcome [2] 306627 0
Frequency of Hospital admission, as reported by participants and assessed at final follow-up visit at 12 months.
Timepoint [2] 306627 0
End of follow-up of 12 months after randomisation.
Primary outcome [3] 306897 0
Time from randomisation to detection of significant arrhythmia by the ILR (tachycardia or bradycardia clinically likely to cause syncope, or >5.5 minutes of new atrial fibrillation).
Timepoint [3] 306897 0
End of follow-up of 12 months after randomisation.
Secondary outcome [1] 348472 0
Physician time spent in total, for each monitoring strategy. Data on time spent collected at the time of patient reviews/interactions/monitoring data review.
Timepoint [1] 348472 0
End of follow-up of 12 months after randomisation.
Secondary outcome [2] 348823 0
Physician time spent - average per-patient for each monitoring strategy. Data on time spent collected at the time of patient reviews/interactions/monitoring data review.
Timepoint [2] 348823 0
End of follow-up of 12 months after randomisation.
Secondary outcome [3] 349099 0
Patient satisfaction assessed on survey specifically designed for this study with scale of 1 to 5 for all responses.
Timepoint [3] 349099 0
End of follow-up of 12 months after randomisation.
Secondary outcome [4] 350047 0
Physician satisfaction assessed on survey specifically designed for this study with scale of 1 to 5 for all responses.
Timepoint [4] 350047 0
End of follow-up of 12 months after randomisation.
Secondary outcome [5] 350048 0
Safety and Tolerability - Major adverse cardiac and cerebrovascular events (MACCE) (non-fatal MI, non-fatal stroke, CV death, cardiac hospitalisation due to heart failure). Data collected from patient medical records and by patient self-report.
Timepoint [5] 350048 0
End of follow-up of 12 months after randomisation.

Eligibility
Key inclusion criteria
Participants with standard indications for an implantable loop recorder.
Minimum age
17 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant or breastfeeding females.
Inability to provide informed consent.

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



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Continuous variables will be reported as mean ± standard deviation or as median and percentiles if appropriate. Normally distributed variables will be compared using the paired Student’s t-test. Otherwise comparisons between both the groups will be performed using the Mann–Whitney U test. Categorical variables will be stated as absolute and relative frequencies and compared using the Chi-square test. All tests are two-tailed. A P-value of <0.05 will be considered as statistically significant. Analysis will be performed of a full analysis set (all participants randomised), as well as on a modified intention to treat (all participants allocated to a monitoring strategy (remote monitoring or office-based), and on a per-protocol basis.

Recruitment
Recruitment status
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
Recruitment hospital [1] 11221 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 11222 0
Lingard Private Hospital - Merewether
Recruitment postcode(s) [1] 23094 0
2305 - New Lambton
Recruitment postcode(s) [2] 23095 0
2291 - Merewether

Funding & Sponsors
Funding source category [1] 299874 0
Hospital
Name [1] 299874 0
John Hunter Hospital, Department of Cardiology
Address [1] 299874 0
Level 3,
Lookout Road
New Lambton Heights
NSW 2305
Country [1] 299874 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital, Department of Cardiology
Address
Level 3,
Lookout Road
New Lambton Heights
NSW 2305
Country
Australia
Secondary sponsor category [1] 299225 0
None
Name [1] 299225 0
Address [1] 299225 0
Country [1] 299225 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300745 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 300745 0
Locked Bag No 1 New Lambton NSW 2305
Ethics committee country [1] 300745 0
Australia
Date submitted for ethics approval [1] 300745 0
04/02/2018
Approval date [1] 300745 0
15/03/2018
Ethics approval number [1] 300745 0
18/02/21/4.06

Summary
Brief summary
Implantable loop recorders (ILR) are used to detect and define heart rhythm problems (cardiac arrhythmias) where symptoms are too infrequent to be captured on non­implantable cardiac rhythm monitoring devices. Currently, the main accepted indication for implantation is recurrent syncope, with a recent addition of cryptogenic stroke as an indication also. Remote monitoring of other implanted cardiac devices (pacemakers and defibrillators) has become the standard of care, based on several randomised trials showing benefits extending across morbidity, mortality, cost effectiveness, and patient satisfaction.

The benefits of remote monitoring of ILRs have not been clearly established. The purpose of this study is to assess the effect of remote monitoring. A comparison between usual office-visit follow-up and remote monitoring only with an initial period of phone-contact will be made. Remote monitoring should lead to action on ILR findings in a shorter time-frame than waiting for the next office visit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84674 0
Dr Bradley Wilsmore
Address 84674 0
Cardiology Department
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Country 84674 0
Australia
Phone 84674 0
+61 2 4921 3000
Fax 84674 0
+61 2 4921 4210
Email 84674 0
Bradley.Wilsmore@hnehealth.nsw.gov.au
Contact person for public queries
Name 84675 0
Dr Bradley Wilsmore
Address 84675 0
Cardiology Department
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Country 84675 0
Australia
Phone 84675 0
+61 2 4921 3000
Fax 84675 0
+61 2 4921 4210
Email 84675 0
Bradley.Wilsmore@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 84676 0
Dr Bradley Wilsmore
Address 84676 0
Cardiology Department
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305
Country 84676 0
Australia
Phone 84676 0
+61 2 4921 3000
Fax 84676 0
+61 2 4921 4210
Email 84676 0
Bradley.Wilsmore@hnehealth.nsw.gov.au

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?
No other documents available
Summary results
No Results