None listed
Conditions
Brief summary
Remote monitoring (RM) has been established as advantageous in the follow-up of patients with implantable cardiac devices as a safe alternative to standard clinic follow-up. While RM is associated with various benefits, compliance is often sub optimal suggesting a more intensive model of RM is required. The aim of the current trial is to determine the clinical utility, feasibility and workflow of implementing an intensive RM program compared to standard RM in patients with implantable cardiac devices. We hypothesize that time from event to action will be shorter for patients in the intensive remote monitoring program compared to participants in the standard remote monitoring program.
Interventions
Intensive Remote Monitoring
Intensive remote monitoring will occur via a cloud-based, automated, vendor-neutral software system with round-the-clock immediate processing of device alerts and scheduled downloads by trained technicians. Processed device data will be rapidly forwarded to the Cardiovascular Centre. The Cardiovascular Centre will access processed data, triaged alerts, and updated patient charts via a single, secure internet-based interface including all device vendors. Data collecte
Intensive Remote Monitoring Intensive remote monitoring will occur via a cloud-based, automated, vendor-neutral software system with round-the-clock immediate processing of device alerts and scheduled downloads by trained technicians. Processed device data will be rapidly forwarded to the Cardiovascular Centre. The Cardiovascular Centre will access processed data, triaged alerts, and updated patient charts via a single, secure internet-based interface including all device vendors. Data collected though the cloud-base system includes all device and patient specific information, including time of alert, time at review, type of alert, time spent per alert response and actionable vs. non-actionable alerts. The standard of care group will consist of 70 patients, randomly selected from the large cohort of patients who receive standard monitoring. Participants for the intervention group will be matched by age, gender and device type to the 70 patients in the standard care group. There is no active participant involvement. Scheduled downloads occur every 6 months. Participants were followed up for 9 months, beginning September 2020. Information regarding subsequent interventions performed will not be collected.
Sponsors
Centre for Heart Rhythm Disorders, University of Adelaide
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
This study will enrol devices across different brands including Biotronik, Boston Scientific, Medtronic and Abbott. The only inclusion criteria is the device is on PaceMate (vendor neutral remote monitoring system). The standard of care group will consist of 70 patients, randomly selected from the large cohort of patients who receive standard monitoring. Participants will be matched by age, gender and device type to those patients in the intensive remote-monitoring group.
Exclusion criteria
Sorin devices on home monitoring as they are not on PaceMate
Outcome results
None listed