Virtual E-health System for Implantable Cardioverter Defibrillators (VIRTUES ICD)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiac Arrhythmia
• Intervention / Treatment: Device: Remote Patient Management; Device: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Actual): 1115
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Remote Patient Management; Patients will be followed by remote monitoring only.	Device: Remote Patient Management; 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
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; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to detection of ventricular arrhythmia events	device-detected ventricular fibrillation or ventricular tachycardia	18 months
Cost effectiveness	An economic evaluation will include a cost utility analysis	18 months
Medication Compliance	Compliance will be measured according to current Canadian Cardiovascular Society Heart Failure Guidelines	18 Months
Minimum programming compliance	Minimum ICD programming according to Canadian Heart Rhythm Society programming recommendations	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	18 months
Inappropriate ICD shocks	Number of inappropriate ICD shocks	18 months
Appropriate ICD shocks	Number of appropriate ICD shocks	18 months
Detection of atrial high-rate episodes	Device detected high-rate episodes greater than 6 minutes	18 months
Number of Cardiovascular-related ER visits	Number of cardiovascular-related visits (<24 hours)	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)	18 Months
Rate of syncope	Syncope	18 months

Collaborators and Investigators

• Sponsor: Ratika Parkash
• Collaborators: Medtronic; Abbott Medical Devices; Cardiac Arrhythmia Network of Canada
• Investigators: Principal Investigator: Ratika Parkash, MD FRCPC, Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: January 15, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac
• Other Study ID Numbers: RP005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No