None listed
Conditions
Brief summary
PRIMARY PURPOSE OF STUDY & STUDY HYPOTHESIS: The primary purpose of this study is to assess the burden of false-positive alerts for an abnormal heart rhythm in patients who have an implantable loop recorder (ILR). An ILR is a small recording device that is implanted under the skin overlying the heart. ILRs are implanted in patients with suspected abnormal heart rhythms, usually for symptoms such as blackouts, palpitations, or strokes without a clear explanation. ILRs record abnormal heart rhythms. These recordings are sent as 'alerts' to a remote monitoring service, with daily review of recordings to allow prompt diagnosis of heart arrhythmias. One small study, conducted over 4 weeks, has shown ILRs to be prone to misdetecting abnormal heart rhythms, and sending alerts that do correspond with a heart arrhythmia; these are known as 'false-positive' alerts. We aim to explore this phenomenon in a large cohort of 1400 ILR patients over a six-month period, and to determine the reasons for this phenomenon. We hypothesis that the false-positive rate, of ILR alerts will be high.
Interventions
We aim to assess the burden of remote monitoring alerts, and the rate of false-positive alerts, in patients with an implantable loop recorder (ILR) in situ, who are receiving remote monitoring of their ILR.
Patients who are connected to the PaceMate remote monitoring service during 6-month study period will be included. Data from these patients is automatically collected routinely as part of the PaceMate remote monitoring database. The data will be sourced from the PaceMate patient registry dat
We aim to assess the burden of remote monitoring alerts, and the rate of false-positive alerts, in patients with an implantable loop recorder (ILR) in situ, who are receiving remote monitoring of their ILR. Patients who are connected to the PaceMate remote monitoring service during 6-month study period will be included. Data from these patients is automatically collected routinely as part of the PaceMate remote monitoring database. The data will be sourced from the PaceMate patient registry database into a spreadsheet. All remote monitoring alerts from patients with a Medtronic ILR in situ, occurring during the 6-month study period (August 2019 until February 2020), will be included. An alert is generated and sent to the remote monitoring service, from the patient's device (ILR) when the device detects an abnormal heart rhythm, or when the patient has symptoms and thus prompts their cardiac device (ILR) to make a recording of their heart rhythm via a remote control. The only patient demographics collected will be age. Remote monitoring alerts will be collected and recorded according to category at the time of transmission (Asystole, Bradycardia, Atrial fibrillation, Tachycardia, or Patient-Activated). All alerts will then be re-categorised according to cardiac technician adjudication, as a true-positive alert or a false-positive alert. The underlying reason for false-positive alert transmission (undersensing, frequent ectopy, oversensing, noise/artifact) will be recorded.
Sponsors
The University of Adelaide
Eligibility
Sex/Gender
All
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients with a Medtronic implantable loop recorder in situ, who were undergoing remote monitoring via the PaceMate remote monitoring service, from 16th August 2019 until 16th February 2020, will be included.
Exclusion criteria
Any patient who did not send at least one alert during the six-month study period will be excluded, as this is the only way to determine which patients were connected to the remote monitoring service during the study period.
Outcome results
None listed