Remote Patient Management of CIEDs - Brady Devices
Remote Patient Management of Cardiac Implantable Electronic Devices - Brady Devices
Ratika Parkash
848 participants
Sep 15, 2020
INTERVENTIONAL
Conditions
Summary
While remote monitoring (RM) technology is currently available and has permitted surveillance and device assessment from any patient location, the use has been inconsistent in Canada, where only 8500 out of a potential 120 000 patients with cardiac implantable electronic devices (CIEDs) are enrolled in this program. This technology is in widespread use worldwide for all CIEDs but in Canada, it is utilized primarily for implantable defibrillators, but not pacemakers. Whereas most of the trials were designed to evaluate the efficacy of RM in implantable cardioverter defibrillator (ICD) patients, in the pacemaker (PM) population, there has been work performed already to demonstrate an increase in detection of frequency of adverse clinical events and a reduction in reaction time to those events by RM. Based on all the available literature, it appears that RM benefits both patients and healthcare systems. Overall, studies have demonstrated that RM can be used safely in all device patient-populations, with the exception of pacemaker-dependent patients. There have been no studies that have evaluated RM only follow up, nor have there been any studies evaluating pacemaker-dependent patients. This study that will safely assess the use of RM only, with in-clinic visits when necessary, that uses the patient-centered electronic platform developed by the Cardiac Arrhythmia Network of Canada (CANet) to perform PM follow up safely, in a more cost-effective manner.
Eligibility
Inclusion Criteria3
- Patients with a Medtronic or Abbott pacemaker capable of remote monitoring.
- Able to provide consent.
- Age >/= 18 years
Exclusion Criteria3
- No access to a family physician or general practioner
- Participation in the RPM CIED pilot study
- Unreliable automated capture verification function by the device in pacemaker-dependent patients
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Interventions
Remote Monitoring only + VIRTUES
In-Clinic visits only
Locations(11)
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NCT03636230