ClinicalTrials.gg
CompletedNCT03405740VIRTUES ICDUpdated Sep 3, 2026

Virtual E-health System for Implantable Cardioverter Defibrillators

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

Phase
Not applicable
Study type
Interventional
Enrollment
1,115
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 73 studies in Arrhythmias, Cardiac with a site in Canada — 13 open to participants now, 15 under way, none of them phase 3. Arrhythmias, Cardiac · Canada.

Enrollment
7th of 49
1,115 · median 240
Started
2020
with 3 others
No phase
25 of 73
4 open now
Registered
46th of 73
by date

Among the 73 studies in Arrhythmias, Cardiac with a site in Canada, this one is the 7th largest by enrollment of the 49 interventional ones that give a count, is one of 4 that started in 2020, is one of 25 with no phase, and was the 46th registered.

Arrhythmias, Cardiac

1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.

Browse Arrhythmias, Cardiac studies →

Open to participants now

13 of the 73 studies in Arrhythmias, Cardiac with a site in Canada are open now. Recruiting first, the newest first:

8 more — sign in →

All 13 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 167 Arrhythmias, Cardiac studies recruiting now, 118 (71%) set no upper age limit and 13 (8%) stop at 75 or younger; 31 take children under 18; 26 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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:

  1. 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).
  2. 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.
03

Conditions studied

  • Cardiac Arrhythmia
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Patients with a Medtronic, Abbott or Boston Scientific defibrillator/CRT-D capable of remote monitoring with Carelink, Merlin or Latitude.
  2. Able to provide consent.
  3. Age >/= 18 years

Exclusion criteria

Exclusion Criteria:

  1. No family physician or general practitioner
  2. Inability to be referred to a specialist
  3. Currently followed more than every 6 months by a Heart Function Clinic
  4. Participation in another randomized clinical trial that impacts outcome
  5. Unreliable automated capture verification by device in pacemaker dependent patient
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,115 participants (actual)

Study arms

  • Active comparator
    Remote Patient Management

    Patients will be followed by remote monitoring only.

    Device: Remote Patient Management

  • Placebo comparator
    Standard of Care

    Remote monitoring at 6 month intervals, alternating with yearly in-clinic visits at their usual site.

    Device: Standard of Care

Interventions

  • DeviceRemote Patient Management

    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

  • DeviceStandard of Care

    No intervention

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Medication Compliance

    Compliance will be measured according to current Canadian Cardiovascular Society Heart Failure Guidelines

    Time frame: 18 Months

  2. Minimum programming compliance

    Minimum ICD programming according to Canadian Heart Rhythm Society programming recommendations

    Time frame: 18 months

  3. 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

  4. Inappropriate ICD shocks

    Number of inappropriate ICD shocks

    Time frame: 18 months

  5. Appropriate ICD shocks

    Number of appropriate ICD shocks

    Time frame: 18 months

  6. Time to detection of ventricular arrhythmia events

    device-detected ventricular fibrillation or ventricular tachycardia

    Time frame: 18 months

  7. Detection of atrial high-rate episodes

    Device detected high-rate episodes greater than 6 minutes

    Time frame: 18 months

  8. Number of Cardiovascular-related ER visits

    Number of cardiovascular-related visits (\<24 hours)

    Time frame: 18 months

  9. 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

  10. Rate of syncope

    Syncope

    Time frame: 18 months

  11. Cost effectiveness

    An economic evaluation will include a cost utility analysis

    Time frame: 18 months

07

Study locations

12 sites
  • Foothills Hospital
    Calgary, Alberta, Canada
  • Victoria Cardiac Arrhythmia Trials
    Victoria, British Columbia V8Z 0B9, Canada
  • St. Boniface Hospital
    Winnipeg, Manitoba, Canada
  • Saint John Regional Hospital
    Saint John, New Brunswick, Canada
  • QEII HSC
    Halifax, Nova Scotia B3H 3A7, Canada
  • St. Mary's General Hospital
    Kitchener, Ontario, Canada
  • London Health Sciences Center
    London, Ontario, Canada
  • Southlake Regional Health Centre
    Newmarket, Ontario L3Y 2P6, Canada
  • Montreal Heart Institute
    Montreal, Quebec H1T 1C8, Canada
  • Hopital SacreCoeur
    Montreal, Quebec, Canada
  • Hopital Laval
    Québec, Quebec G1V 4G5, Canada
  • Centre Hospitalier Universitaire de Sherbrooke
    Sherbrooke, Quebec J1H 5N4, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2020 to primary completion in Apr 2026, 71 months.

Of 171 non-industry interventional studies with no phase under Arrhythmias, Cardiac, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 43. This study's 71 months is above that.

Counting every sponsor, half of 242 studies reached it within 24 months; a quarter within 12 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 15, 2018
First posted
Jan 23, 2018
StartActual
May 1, 2020
Primary completionActual
Apr 30, 2026
CompletionActual
Jun 30, 2026
Last update
Sep 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03405740
Lead sponsor
Ratika Parkash
Collaborators
Cardiac Arrhythmia Network of Canada, Abbott Medical Devices, Medtronic
Responsible party
Ratika Parkash (Staff Electrophysiologist, Nova Scotia Health Authority) — Sponsor-investigator
First posted
Jan 23, 2018
Start date
May 1, 2020
Primary completion
Apr 30, 2026
Completion
Jun 30, 2026
Last update
Sep 3, 2026

Study contacts

Ratika Parkash, MD FRCPC
principal investigator · Nova Scotia Health Authority

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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