All studies
Active not recruitingNAINTERVENTIONAL

Virtual E-health System for Implantable Cardioverter Defibrillators

This study, called "Virtual E-health System for Implantable Cardioverter Defibrillators" (VIRTUES), is for people with heart rhythm problems who have a special implanted device, like a pacemaker or defibrillator. These devices help keep your heart beating regularly. The study wants to see if using a new e-health system to check these devices remotely from home is as good as, or even better than, the usual way of having check-ups at the hospital. This could mean fewer trips to the hospital, especially for those who live far away. It's a Canadian study comparing remote care to standard care to see which approach works best.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
Ratika Parkash
Enrolment target
1,115
Start
01 May 2020
Estimated completion
30 Jun 2026

What is this study about?

If you have a heart device like a pacemaker or a defibrillator, you might be interested in this study. These devices are very helpful for people with heart rhythm problems, but they usually require regular check-ups at the hospital. This can be difficult for some, especially if they live far away or find travelling hard.

This study is exploring a new idea called 'remote patient management' for people with these devices. Instead of frequent hospital visits, the plan is to use a special e-health system that can monitor your device from your home. This means your doctors can keep an eye on how your device is working without you needing to travel. The study aims to see if this new, fully remote way of monitoring is as safe and effective as the traditional way of coming to the clinic.

The main goal is to make healthcare for people with heart devices easier and more accessible, particularly for those in rural areas of Canada where travel distances can be long. This new system could help you understand your device better and allow your local healthcare team to look after you more easily, all while reducing the need for long journeys to specialist clinics. It's about using modern technology to improve how your heart device is managed.

Key takeaways

  • This study evaluates new remote monitoring for heart devices.
  • It aims to reduce hospital visits for people with pacemakers or defibrillators.
  • You'll be assigned either remote care or usual care randomly.
  • Could make healthcare more accessible, especially for those in rural areas.
  • Participants must be 18+ with specific Medtronic, Abbott, or Boston Scientific devices.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a specific type of heart device. These devices include defibrillators or CRT-Ds made by Medtronic, Abbott, or Boston Scientific, and they must be able to send information remotely using their own special systems (like Carelink, Merlin, or Latitude).

You also need to be able to understand the study and agree to take part. Importantly, you should have a GP or family doctor who can look after your general health. You also can't be getting very frequent check-ups (more often than every 6 months) at a Heart Function Clinic, or already be taking part in another clinical trial that might affect the results of this one.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have a Medtronic, Abbott, or Boston Scientific defibrillator or CRT-D device that can be monitored remotely?
  3. Do you have a family doctor or GP?
  4. Are you able to agree to take part in the study?
  5. Are you not currently part of another clinical trial that might affect your health outcomes?
Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll be chosen by chance (like flipping a coin) to either receive remote monitoring of your heart device through the new VIRTUES system or continue with your usual care. You won't get to choose which group you're in. The study will look at how well the remote monitoring works compared to standard care over time. This means attending your appointments as usual for your heart device checks, whether they are remote or in-person, as assigned to your group. The total duration of your participation in the study is not specified but will be for a period of ongoing follow-up for your heart device.

Potential risks and benefits

Participating in this study might offer you the benefit of more convenient monitoring of your heart device, potentially reducing the need for travel to hospital appointments, especially if you're in the remote monitoring group. This could improve your understanding of your device's function. As with any study involving medical devices, there's always a small chance that the new monitoring system might not work as expected or that you could experience issues that would normally be picked up in a face-to-face appointment. However, the study aims to ensure patient safety and will have systems in place. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

  • Foothills Hospital
    Verified postcode
    Calgary, Canada
  • Victoria Cardiac Arrhythmia Trials
    Verified postcode
    Victoria, Canada
  • St. Boniface Hospital
    Verified postcode
    Winnipeg, Canada
  • Saint John Regional Hospital
    Verified postcode
    Saint John, Canada
  • QEII HSC
    Verified postcode
    Halifax, Canada
  • St. Mary's General Hospital
    Verified postcode
    Kitchener, Canada
  • London Health Sciences Center
    Verified postcode
    London, Canada
  • Southlake Regional Health Centre
    Verified postcode
    Newmarket, Canada
  • Montreal Heart Institute
    Verified postcode
    Montreal, Canada
  • Hopital SacreCoeur
    Verified postcode
    Montreal, Canada
  • Hopital Laval
    Verified postcode
    Québec, Canada
  • Centre Hospitalier Universitaire de Sherbrooke
    Verified postcode
    Sherbrooke, Canada

Common questions

What kind of heart devices is this study looking at?

It's for people who have special implanted heart devices, like defibrillators or CRT-Ds, made by Medtronic, Abbott, or Boston Scientific.

What does 'remote patient management' mean?

It means your heart device is monitored by doctors from a distance, using technology, so you don't always have to go into the clinic for check-ups.

Will I have to travel for this study?

The study is designed to explore ways to reduce travel, especially for check-ups. Depending on which group you're in, you might have fewer clinic visits.

Can I choose whether I get remote monitoring or standard care?

No, you will be randomly assigned to one of the groups, like drawing lots, to make sure the study results are fair.

Who is eligible to join?

You need to be over 18, have one of the specific heart devices mentioned, and have a local GP, among other criteria.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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