Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03636230

Virtual 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Pacemaker

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

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with a Medtronic or Abbott pacemaker capable of remote monitoring.
  • Able to provide consent.
  • Age >/= 18 years

Exclusion criteria

  • 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

Treatment and study plan

remote monitoring

Device

Remote Monitoring only + VIRTUES

Standard of care

Other

In-Clinic visits only

Primary outcomes

  1. 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.

  2. 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)

Secondary outcomes

  1. Quality of Life - Short Form (SF36)

    Time frame: 18 months

    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

  2. Quality of Life - Florida Patient Acceptance Survey (FPAS)

    Time frame: 18 months

    The FPAS produces scores that range from 0-100, where higher scores indicate increased device acceptance.

  3. Quality of Life - Florida Shock Anxiety Scale (FSAS)

    Time frame: 18 months

    The FSAS produces scores that range from 10-50. Higher scores signify increased shock anxiety.

  4. Quality of Life - Brief Illness Perception Questionnaire (BIPQ)

    Time frame: 18 months

    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.

  5. Number of patients with device-related ER visits

    Time frame: 18 months

    Rate of device-related ER visits (<24 hours)

  6. Number of patients with syncope

    Time frame: 18 months

    Rate of syncope

  7. Number of patients experiencing ventricular arrhythmia events

    Time frame: 18 months

    Rate of ventricular arrhythmia episodes detected by the pacemaker

  8. Number of patients with atrial fibrillation

    Time frame: 18 months

    Rate of AF greater than 6 minutes detected by the pacemaker

Sponsors and collaborators

Lead sponsor

Ratika Parkash

Other

Collaborators

  • Abbott
  • Cardiac Arrhythmia Network of Canada
  • Medtronic

Registry information

Official study title

Virtual Integrated Reliable Transformative User-driven E-health System for Pacemakers

Acronym: VIRTUES PM

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2018
Registry last updated
May 15, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.