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OpenTrials
Active, Not Recruiting

NCT Number: NCT03405740

Virtual 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Hospital, Calgary, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Remote Patient Management

Device
  • 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 care

Device

No intervention

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Medication Compliance

    Time frame: 18 Months

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

  2. Minimum programming compliance

    Time frame: 18 months

    Minimum ICD programming according to Canadian Heart Rhythm Society programming recommendations

  3. Number of clinical events leading to a change in medication

    Time frame: 18 months

    Events detected by the ICD that lead to a clinical decision to change medication

  4. Inappropriate ICD shocks

    Time frame: 18 months

    Number of inappropriate ICD shocks

  5. Appropriate ICD shocks

    Time frame: 18 months

    Number of appropriate ICD shocks

  6. Time to detection of ventricular arrhythmia events

    Time frame: 18 months

    device-detected ventricular fibrillation or ventricular tachycardia

  7. Detection of atrial high-rate episodes

    Time frame: 18 months

    Device detected high-rate episodes greater than 6 minutes

  8. Number of Cardiovascular-related ER visits

    Time frame: 18 months

    Number of cardiovascular-related visits (<24 hours)

  9. Number of Device-Related ER visits

    Time frame: 18 Months

    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)

  10. Rate of syncope

    Time frame: 18 months

    Syncope

  11. Cost effectiveness

    Time frame: 18 months

    An economic evaluation will include a cost utility analysis

Sponsors and collaborators

Lead sponsor

Ratika Parkash

Other

Collaborators

  • Abbott Medical Devices
  • Cardiac Arrhythmia Network of Canada
  • Medtronic

Registry information

Official study title

Virtual Integrated Reliable Transformative User-driven E-health System for Implantable Cardioverter Defibrillators

Acronym: VIRTUES ICD

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2018
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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