Virtual E-health System for Implantable Cardioverter Defibrillators (NCT03405740) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Virtual E-health System for Implantable Cardioverter Defibrillators
Canada1,115 participantsStarted 2020-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to major adverse cardiac event (primary safety outcome)
Timeframe: 18 months
2
Time to a device-detected event (primary efficacy outcome)