VIRTUES
Virtual Integrated Reliable Transformative User-driven E-health System for Implantable Cardioverter Defibrillators (VIRTUES ICD) and for Pacemakers (VIRTUES PM) — listed in the programme as "VIRTUES ICD / VIRTUES PM"
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 1,963 patients with an ICD or pacemaker, remote-only device management via an e-health platform was compared with scheduled in-clinic follow-up on major adverse cardiac events at 18 months.
N
1.963
Design
two parallel investigator-initiated, open-label, randomised 1:1 trials across Canadian device clinics (12 sites ICD, 11 sites PM; PM trial stratified by site and pacemaker dependence); remote patient management via the CANet VIRTUES platform without routine in-clinic device visits vs standard of care; 18-month follow-up
Endpunkt
VIRTUES ICD — co-primary: time to major adverse cardiac event (safety: death, stroke, hospitalisation for device-system complications, cardiovascular hospitalisation, syncope, device-related emergency visits) and time from device-detected event to clinical decision (efficacy), at 18 months. VIRTUES PM — co-primary: time to major adverse cardiac event (death, stroke, unplanned cardiovascular hospitalisation) and cost-effectiveness (incremental cost per QALY), at 18 months