PacemakerVIRTUES PMNCT03636230
Virtual E-health System for Pacemakers
A study testing Remote Monitoring in people with Pacemaker, run by Ratika Parkash at 11 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker
- What is being tested?
- Remote Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 848 participants
- Where
- 11 sitesCanada
- Study dates
- 15 Sep 2020to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a Medtronic or Abbott pacemaker capable of remote monitoring.
- Able to provide consent.
- Age >/= 18 years
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Canada11 sites
Foothills Hospital
Calgary, Alberta, T2N 4Z6
QEII Health Sciences Center
Halifax, Nova Scotia, B3H 3A7
St. Mary's General Hospital
Kitchener, Ontario
London Health Sciences Centre
London, Ontario, N6A 5W5
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Hopital Sacre Coeur
Montreal, Quebec
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9
Hopital Laval
Québec, Quebec
Centre Hospitalier Universitaire du Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Memorial University of Newfoundland Hospital
St. John's, Newfoundland and Labrador
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, V8T 1Z8
About this study
Official title: Virtual Integrated Reliable Transformative User-driven E-health System for Pacemakers
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.
Read the detailed description
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):
- Patients will be followed by remote monitoring only. 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 device clinic. The proposed intervention would eliminate any routine visits.
- Newly implanted pacemaker patients will be seen after the initial implant at the hub site, within 48 hours and then within 3 months to optimize programming for subsequent RM visits. Thereafter, all follow-up will occur through remote monitoring every six months. Unscheduled remote transmissions may also occur. Using a combination of remote monitoring, and novel technology, VIRTUES, patients will be managed outside of the clinic.
- Patients will be provided with real-time knowledge of success of their remote transmission and the status of the remote through a web-based portal called VIRTUES.
- Virtual patient record - all patient information in the intervention arm will be contained within an information cloud that will be accessible by patients; access to their own data may be granted by the patient themselves to permit delivery of care remotely, and to permit after hours follow up to be performed by the on call personnel.
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.
- Conditions
- Pacemaker
- Being tested
- Remote Monitoring, Standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote MonitoringDevice
Remote Monitoring only + VIRTUES
Standard of careOther
In-Clinic visits only
| Study group | Role | What they receive |
|---|---|---|
| Remote Patient Management | Active comparator | Remote monitoring only Receives: Device: Remote Monitoring |
| Standard of Care | Placebo comparator | In-clinic visits Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 18 months
Secondary outcomes (8)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 months
Number of patients with device-related ER visits
Rate of device-related ER visits (<24 hours)
Measured: 18 months
Number of patients with syncope
Rate of syncope
Measured: 18 months
Number of patients experiencing ventricular arrhythmia events
Rate of ventricular arrhythmia episodes detected by the pacemaker
Measured: 18 months
Number of patients with atrial fibrillation
Rate of AF greater than 6 minutes detected by the pacemaker
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start15 Sep 2020
- Primary completion30 Apr 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PacemakerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label, 1:1 randomized trial, stratified by site and pacemaker dependence
- Masking
- None (open label)
- Enrolment
- 848 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ratika Parkash
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiac Arrhythmia Network of Canada, Medtronic, Abbott
- Responsible party
- Sponsor-investigator, Ratika Parkash, Nova Scotia Health Authority
- Investigators
- Ratika Parkash, MD FRCPC, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636230
- Sponsor's protocol ID
- RP-006
- Acronym
- VIRTUES PM
- Status last verified
- Sep 2026
- First submitted
- 23 Jan 2018
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Integrated Reliable Transformative User-driven E-health System for Pacemakers
- ClinicalTrials.gov ID
- NCT03636230
- Acronym / sponsor ID
- VIRTUES PM / RP-006
- Conditions
- Pacemaker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 848 participants (actual)
- Lead sponsor
- Ratika ParkashUniversity, hospital or other
- Collaborators
- Cardiac Arrhythmia Network of Canada, Medtronic, Abbott
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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):
- Patients will be followed by remote monitoring only. 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 device clinic. The proposed intervention would eliminate any routine visits.
- Newly implanted pacemaker patients will be seen after the initial implant at the hub site, within 48 hours and then within 3 months to optimize programming for subsequent RM visits. Thereafter, all follow-up will occur through remote monitoring every six months. Unscheduled remote transmissions may also occur. Using a combination of remote monitoring, and novel technology, VIRTUES, patients will be managed outside of the clinic.
- Patients will be provided with real-time knowledge of success of their remote transmission and the status of the remote through a web-based portal called VIRTUES.
- Virtual patient record - all patient information in the intervention arm will be contained within an information cloud that will be accessible by patients; access to their own data may be granted by the patient themselves to permit delivery of care remotely, and to permit after hours follow up to be performed by the on call personnel.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, 1:1 randomized trial, stratified by site and pacemaker dependence
| Arm | Type | Receives |
|---|---|---|
| Remote Patient Management | Active comparator | Device: Remote MonitoringRemote monitoring only |
| Standard of Care | Placebo comparator | Other: Standard of careIn-clinic visits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a Medtronic or Abbott pacemaker capable of remote monitoring.
- Able to provide consent.
- Age >/= 18 years
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote MonitoringRemote Monitoring only + VIRTUES | Device | Remote Patient Management |
| Standard of careIn-Clinic visits only | Other | Standard of Care |
Primary outcome
Time to major adverse cardiac event (MACE)
Time frame: 18 months
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.
Cost effectiveness
Time frame: 18 months
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)
8 secondary outcomes
Quality of Life - Short Form (SF36)
Time frame: 18 months
Quality of Life - Florida Patient Acceptance Survey (FPAS)
Time frame: 18 months
Quality of Life - Florida Shock Anxiety Scale (FSAS)
Time frame: 18 months
Quality of Life - Brief Illness Perception Questionnaire (BIPQ)
Time frame: 18 months
Number of patients with device-related ER visits
Time frame: 18 months
Number of patients with syncope
Time frame: 18 months
Number of patients experiencing ventricular arrhythmia events
Time frame: 18 months
Number of patients with atrial fibrillation
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ratika Parkash, MD FRCPC principal investigator
Nova Scotia Health Authority
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Monitoring in people with Pacemaker, run by Ratika Parkash at 11 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to major adverse cardiac event (MACE) (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.