An interventional study of Remote Monitoring and Standard of care in Pacemaker, sponsored by Ratika Parkash. Completed at 11 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
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.
This is a Canadian multicenter randomized controlled trial to assess remote patient management. Patients will be randomized in a 1:1 fashion, stratified by pacemaker dependence and by center to either remote patient management of standard of care.
Remote patient management (intervention group):
Standard of care (comparison group):
The standard arm will be required to have in-clinic visits at yearly intervals. These patients would not have access to the virtual patient cloud or to remote monitoring.
Pacemaker programming: All patients in both arms will undergo programming as per the ASSERT II protocol (previously published) to optimize pacemaker parameters and detection of atrial and ventricular high rate episodes.
Ratika Parkash is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Remote monitoring only
Device: Remote Monitoring
In-clinic visits
Other: Standard of care
Remote Monitoring only + VIRTUES
In-Clinic visits only
Time to major adverse cardiac event (MACE)
Includes: death, stroke, hospitalization for a cardiovascular cause (unplanned hospitalization with an overnight stay in hospital) due to one of the following causes: acute coronary syndrome, presyncope / syncope, transient ischemic attack / stroke, ventricular arrhythmias, atrial fibrillation, flutter, pulmonary embolism / deep vein thrombosis /systemic embolism, worsening congestive heart failure including pulmonary edema or dyspnea of cardiac origin.
Time frame: 18 months
Cost effectiveness
Cost comparison between groups (VIRTUES strategy versus Standard of Care). Analysis will take the form of a cost utility analysis with cost effectiveness assessed in terms of the incremental cost per quality life year (QALY)
Time frame: 18 months
Quality of Life - Short Form (SF36)
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health
Time frame: 18 months
Quality of Life - Florida Patient Acceptance Survey (FPAS)
The FPAS produces scores that range from 0-100, where higher scores indicate increased device acceptance.
Time frame: 18 months
Quality of Life - Florida Shock Anxiety Scale (FSAS)
The FSAS produces scores that range from 10-50. Higher scores signify increased shock anxiety.
Time frame: 18 months
Quality of Life - Brief Illness Perception Questionnaire (BIPQ)
Individual item analysis will be used in this study. The personal control score is the response to item 3. The treatment control score is the response to item 4. Illness concern is measured by item 6. This reflects a combination of emotional and cognitive representations. Scores on these individual items range from 0-10 where higher scores on personal and treatment concern are reflected in higher scores. Higher scores on illness concern are reflected in higher scores.
Time frame: 18 months
Number of patients with device-related ER visits
Rate of device-related ER visits (\<24 hours)
Time frame: 18 months
Number of patients with syncope
Rate of syncope
Time frame: 18 months
Number of patients experiencing ventricular arrhythmia events
Rate of ventricular arrhythmia episodes detected by the pacemaker
Time frame: 18 months
Number of patients with atrial fibrillation
Rate of AF greater than 6 minutes detected by the pacemaker
Time frame: 18 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2020 to primary completion in Apr 2026, 67 months.
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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