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Remote Monitoring impact on cardiac arrhythmia detection in Adults with Implantable Loop Recorders

A Randomised, Controlled Trial of Remote Monitoring versus office-based follow-up for cardiac arrhythmia detection in Adults with Implantable Loop Recorders.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001359224
Enrollment
100
Registered
2018-08-13
Start date
2018-04-18
Completion date
2019-09-10
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

John Hunter Hospital, Department of Cardiology
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
17 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

Participants with standard indications for an implantable loop recorder.

Exclusion criteria

Pregnant or breastfeeding females. Inability to provide informed consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 19, 2026