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Intensive Follow-up via Remote Monitoring of Implantable Cardioverter Defibrillators in people with severe left ventricular dysfunction.

The effectiveness of Intensive Follow-up via Remote Monitoring of Implantable Cardioverter Defibrillators in people with severe left ventricular dysfunction.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001451190
Acronym
INFORM-ICD
Enrollment
840
Registered
2019-10-18
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-10-28

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 cardioverter-defibrillators (ICDs) are common for prevention of sudden cardiac death in patients with heart muscle dysfunction. Traditionally, ICDs have been followed up via clinic visits every 3 to 6 months. Remote monitoring of ICDs has become more common, allowing for early detection and intervention following clinical or device related events. However, in practice many patients do not receive remote monitoring, and those that do have sub-optimal compliance, suggesting more intensive management of remote monitoring may be better. This project aims to evaluate the efficacy of an intensive remote monitory strategy to help improve treatment and outcomes for ICD patients.

Interventions

Standard Remote Monitoring: Each site selected to participate in the study is currently participating in remote monitoring. Sites will continue undertaking remote monitoring. Clinic staff will access RM data via individual device vendor internet-based interfaces. Response to RM data transmissions will be at the discretion of site investigators. Managed Remote Monitoring: Managed remote monitoring will occur via a cloud-based, automated, vendor-neutral software system with round-the-clock (inclu

Standard Remote Monitoring: Each site selected to participate in the study is currently participating in remote monitoring. Sites will continue undertaking remote monitoring. Clinic staff will access RM data via individual device vendor internet-based interfaces. Response to RM data transmissions will be at the discretion of site investigators. Managed Remote Monitoring: Managed remote monitoring will occur via a cloud-based, automated, vendor-neutral software system with round-the-clock (including overnight, weekend, public holiday) immediate processing of device alerts and scheduled downloads by trained technicians. Processed device data will be rapidly forwarded to investigational sites. Investigational sites will access processed data, triaged alerts, and updated patient charts via a single, secure internet-based interface including all device vendors. The system will include direct contact made with patients in the event of device transmission failure. All patients will receive a transmitter to plug in at home next to the bed. Overnight, the transmitter communicates with the ICF and sends messages to the clinic. The participant will not be responsible for sending transmissions as the process is automated. The total duration of the intervention is 24 months. Those patients randomised to the intensively managed remote monitoring group, or the standard remote monitoring group, will have any data transmitted to the clinic reviewed, and will be contacted in the event of a problem, or in the event that the clinic has not received communication from your ICD for 7 days. Those patients randomised to clinic follow-up without remote monitoring will have their ICD checked every 6 months during their clinic visit.

Sponsors

Centre for Heart Rhythm Disorders, University of Adelaide
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

ICD or CRT-D with remote monitoring capabilities Left ventricular ejection fraction (LVEF) equal to or less than 35% Willing and able to participate in remote ICD/CRT-D monitoring Age at least 18 years

Exclusion criteria

Channelopathies Hypertrophic or restrictive cardiomyopathies Arrhythmogenic right ventricular dysplasia ICD/CRT-D lead under advisory Enrolled in or with intention to participate in a clinical drug and/or device trial which has potential to confound results of this Life expectancy less than 24 months

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026