Cardiac ArrhythmiaVIRTUES ICDNCT03405740
Virtual E-health System for Implantable Cardioverter Defibrillators
A study testing Remote Patient Management in people with Cardiac Arrhythmia, run by Ratika Parkash at 12 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- Remote Patient Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,115 participants
- Where
- 12 sitesCanada
- Study dates
- 1 May 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, Abbott or Boston Scientific defibrillator/CRT-D capable of remote monitoring with Carelink, Merlin or Latitude.
- Able to provide consent.
- Age >/= 18 years
Who cannot join
- No family physician or general practitioner
- Inability to be referred to a specialist
- Currently followed more than every 6 months by a Heart Function Clinic
- Participation in another randomized clinical trial that impacts outcome
- Unreliable automated capture verification by device in pacemaker dependent patient
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Canada12 sites
Foothills Hospital
Calgary, Alberta
QEII HSC
Halifax, Nova Scotia, B3H 3A7
St. Mary's General Hospital
Kitchener, Ontario
London Health Sciences Center
London, Ontario
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Hopital SacreCoeur
Montreal, Quebec
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P6
Hopital Laval
Québec, Quebec, G1V 4G5
Saint John Regional Hospital
Saint John, New Brunswick
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, V8Z 0B9
St. Boniface Hospital
Winnipeg, Manitoba
About this study
Official title: Virtual Integrated Reliable Transformative User-driven E-health System for Implantable Cardioverter Defibrillators
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.
Read the detailed description
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:
- Remote View: this secure, web-based portal facilitates a virtual view of the device programming by the specialist in real-time while the patient is in their local clinic, thus avoiding patient travel to the specialized clinic (hub).
- VIRTUES (Virtual Integrated Reliable Transformative User-driven E-health System): this portal has been developed by the Cardiac Arrhythmia Network of Canada to allow the patient to receive reports from the remote transmissions of their device.
- Conditions
- Cardiac Arrhythmia
- Being tested
- Remote Patient Management, Standard of Care
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Patient ManagementDevice
- 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.
- All patients will be required to follow up with their family physician at least annually, and their cardiologist at least every 2 years.
- 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)
- VIRTUES access
Standard of CareDevice
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Remote Patient Management | Active comparator | Patients will be followed by remote monitoring only. Receives: Device: Remote Patient Management |
| Standard of Care | Placebo comparator | Remote monitoring at 6 month intervals, alternating with yearly in-clinic visits at their usual site. Receives: Device: 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 (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.
Measured: 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
Measured: 18 months
Secondary outcomes (11)
Medication Compliance
Compliance will be measured according to current Canadian Cardiovascular Society Heart Failure Guidelines
Measured: 18 Months
Minimum programming compliance
Minimum ICD programming according to Canadian Heart Rhythm Society programming recommendations
Measured: 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
Measured: 18 months
Inappropriate ICD shocks
Number of inappropriate ICD shocks
Measured: 18 months
Appropriate ICD shocks
Number of appropriate ICD shocks
Measured: 18 months
Time to detection of ventricular arrhythmia events
device-detected ventricular fibrillation or ventricular tachycardia
Measured: 18 months
Detection of atrial high-rate episodes
Device detected high-rate episodes greater than 6 minutes
Measured: 18 months
Number of Cardiovascular-related ER visits
Number of cardiovascular-related visits (<24 hours)
Measured: 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)
Measured: 18 Months
Rate of syncope
Syncope
Measured: 18 months
Cost effectiveness
An economic evaluation will include a cost utility analysis
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 posted23 Jan 2018
- Study start1 May 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 Cardiac ArrhythmiaStudies 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
- Masking
- None (open label)
- Enrolment
- 1,115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ratika Parkash
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiac Arrhythmia Network of Canada, Abbott Medical Devices, Medtronic
- 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
- NCT03405740
- Sponsor's protocol ID
- RP005
- Acronym
- VIRTUES ICD
- Status last verified
- Sep 2026
- First submitted
- 15 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 Implantable Cardioverter Defibrillators
- ClinicalTrials.gov ID
- NCT03405740
- Acronym / sponsor ID
- VIRTUES ICD / RP005
- Conditions
- Cardiac Arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,115 participants (actual)
- Lead sponsor
- Ratika ParkashUniversity, hospital or other
- Collaborators
- Cardiac Arrhythmia Network of Canada, Abbott Medical Devices, Medtronic
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 23 Jan 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.
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.
Detailed description
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:
- Remote View: this secure, web-based portal facilitates a virtual view of the device programming by the specialist in real-time while the patient is in their local clinic, thus avoiding patient travel to the specialized clinic (hub).
- VIRTUES (Virtual Integrated Reliable Transformative User-driven E-health System): this portal has been developed by the Cardiac Arrhythmia Network of Canada to allow the patient to receive reports from the remote transmissions of their device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Patient Management | Active comparator | Device: Remote Patient ManagementPatients will be followed by remote monitoring only. |
| Standard of Care | Placebo comparator | Device: Standard of CareRemote monitoring at 6 month intervals, alternating with yearly in-clinic visits at their usual site. |
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, Abbott or Boston Scientific defibrillator/CRT-D capable of remote monitoring with Carelink, Merlin or Latitude.
- Able to provide consent.
- Age >/= 18 years
Key exclusion criteria (5 listed)
- No family physician or general practitioner
- Inability to be referred to a specialist
- Currently followed more than every 6 months by a Heart Function Clinic
- Participation in another randomized clinical trial that impacts outcome
- Unreliable automated capture verification by device in pacemaker dependent patient
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 Patient Management1. 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 | Device | Remote Patient Management |
| Standard of CareNo intervention | Device | Standard of Care |
Primary outcome
Time to major adverse cardiac event (primary safety outcome)
Time frame: 18 months
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 to a device-detected event (primary efficacy outcome)
Time frame: 18 months
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
11 secondary outcomes
Medication Compliance
Time frame: 18 Months
Minimum programming compliance
Time frame: 18 months
Number of clinical events leading to a change in medication
Time frame: 18 months
Inappropriate ICD shocks
Time frame: 18 months
Appropriate ICD shocks
Time frame: 18 months
Time to detection of ventricular arrhythmia events
Time frame: 18 months
Detection of atrial high-rate episodes
Time frame: 18 months
Number of Cardiovascular-related ER visits
Time frame: 18 months
Number of Device-Related ER visits
Time frame: 18 Months
Rate of syncope
Time frame: 18 months
Cost effectiveness
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
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Patient Management in people with Cardiac Arrhythmia, run by Ratika Parkash at 12 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 5 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 12 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 (primary safety outcome) (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; AzTrials last refreshed its copy on 30 Oct 2026.