An interventional study of Remote Patient Management and Standard of Care in Cardiac Arrhythmia, sponsored by Ratika Parkash. Completed at 12 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Ratika Parkash · Not applicable, Interventional, and Treatment
This is a Canadian multicenter randomized controlled trial to assess remote patient management. Patients will be randomized to remote patient management with VIRTUES versus usual care, and will be stratified by RemoteView vs no RemoteView utilization, as well as by center.
Remote monitoring (RM) has been in use for over a decade and is now used in a blended system of in clinic visits and RM to provide CIED follow up. Prior studies have focused on this blended model of follow up. In this study, we propose a paradigm shift in CIED follow up care that is fully remote, supported by a patient-centered communication system permitting patients to have greater understanding of their CIED and its function. Patients would not have to leave their own communities to obtain state-of-the art care for their cardiac condition or their CIED. Given the burgeoning use of CIEDs (ICDs and PMs), the aging population and particularly in Canada where 19% of the inhabitants are in communities classified as 'rural', many have long distances to travel to reach a health care facility, it is of the utmost importance to take full advantage of available and developing technologies to improve CIED follow up beyond current recommendations. During the life of these patients, many issues may arise, such as atrial or ventricular arrhythmias that may result in syncope, stroke or sudden death, need for increased monitoring resulting from device advisories, or minor programming adjustments to improve device performance, or simply the need for enhanced surveillance as the device battery depletes and replacement is anticipated. New technology has become available that not only permits surveillance, but also permits communication back to the patient, and their respective providers regarding the status of these devices. The combination of technologies will result in a total care of CIEDs termed Remote Patient Management - CIED (RPM-CIED). The incorporation of enhanced monitoring capability, along with automatic recalibration of device settings, allows us to develop a new paradigm of remote patient management where after the patient receives their device, they would remain in the care of their local health team ('spokes') and no longer require travel to the specialized device clinics ('hubs') for follow-up. It creates capacity in the specialized centers to focus exclusively on the problematic cases by removing the need for routine checks.
There are two avenues of new technology that will be used in this study:
Exclusion Criteria:
Patients will be followed by remote monitoring only.
Device: Remote Patient Management
Remote monitoring at 6 month intervals, alternating with yearly in-clinic visits at their usual site.
Device: Standard of Care
1. Transmissions will occur at six monthly intervals, with no in-clinic visits. If there is an actionable event on the remote transmission, patients will be seen at their closest community clinic. 2. All patients will be required to follow up with their family physician at least annually, and their cardiologist at least every 2 years. 3. Patients will be contacted by phone at 6 months and 12 months to document their current health status (change in cardiovascular medications, any cardiovascular hospitalizations, in-clinic device checks, or any new cardiovascular testing completed since the last visit) 4. VIRTUES access
No intervention
Time to major adverse cardiac event (primary safety outcome)
Time to a major adverse event, including: death, stroke, hospitalization for complications relating to the device system, cardiovascular hospitalization, syncope, device-related Emergency Department visits.
Time frame: 18 months
Time to a device-detected event (primary efficacy outcome)
The response time from a clinical event to a clinical decision in response to arrhythmias, cardiovascular disease progression, and device issues with remote patient management as compared to standard of care
Time frame: 18 months
Medication Compliance
Compliance will be measured according to current Canadian Cardiovascular Society Heart Failure Guidelines
Time frame: 18 Months
Minimum programming compliance
Minimum ICD programming according to Canadian Heart Rhythm Society programming recommendations
Time frame: 18 months
Number of clinical events leading to a change in medication
Events detected by the ICD that lead to a clinical decision to change medication
Time frame: 18 months
Inappropriate ICD shocks
Number of inappropriate ICD shocks
Time frame: 18 months
Appropriate ICD shocks
Number of appropriate ICD shocks
Time frame: 18 months
Time to detection of ventricular arrhythmia events
device-detected ventricular fibrillation or ventricular tachycardia
Time frame: 18 months
Detection of atrial high-rate episodes
Device detected high-rate episodes greater than 6 minutes
Time frame: 18 months
Number of Cardiovascular-related ER visits
Number of cardiovascular-related visits (\<24 hours)
Time frame: 18 months
Number of Device-Related ER visits
ER visits (\<24 hrs) for a device-related reason (including an audio signal from the device (beeping), shock(s), or a device complication requiring medical attention)
Time frame: 18 Months
Rate of syncope
Syncope
Time frame: 18 months
Cost effectiveness
An economic evaluation will include a cost utility analysis
Time frame: 18 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Ratika Parkash