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Recruiting NCT03636230

Remote Patient Management of CIEDs - Brady Devices

Trial Parameters

Condition Pacemaker
Sponsor Ratika Parkash
Study Type INTERVENTIONAL
Phase N/A
Enrollment 848
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-09-15
Completion 2025-02-28
Interventions
Remote MonitoringStandard of care

Brief 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 Criteria

Inclusion Criteria: * Patients with a Medtronic or Abbott pacemaker capable of remote monitoring. * Able to provide consent. * Age \>/= 18 years Exclusion Criteria: * 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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