Active not recruitingNAINTERVENTIONAL

Virtual E-health System for Pacemakers

This study is investigating a new way to monitor pacemakers using a virtual e-health system. Instead of regular hospital visits, patients would have their pacemaker checked remotely from home. This could make managing pacemakers more convenient and potentially save money. The study compares this new remote monitoring approach with the usual care, where patients have scheduled clinic appointments. Researchers want to see if remote monitoring, with clinic visits only when truly needed, is safe and effective for people with pacemakers. They are also looking at how patients can access their own health information through a special online portal.

At a glance

Status

Active not recruiting

Phase

Sponsor

Ratika Parkash

Enrolment target

848

Start

15 Sep 2020

Estimated completion

30 Jun 2026

Pacemaker

What is this study about?

This research is looking at a new way to keep an eye on people's pacemakers. Many pacemakers can already send information remotely, meaning doctors can check them without you having to come into the clinic. While this technology is good, it's not always used for all types of pacemakers. This study aims to see if we can safely and effectively use remote monitoring as the main way to follow up with pacemaker patients, only needing clinic visits if there's a problem that needs immediate attention.

Currently, many people with pacemakers have regular appointments at the hospital or clinic. This study is exploring a different approach: what if all your routine checks were done remotely? The goal is to make managing your pacemaker more convenient for you and potentially more efficient for the healthcare system. The study uses a special online system called VIRTUES, which allows you to keep track of your pacemaker's information and even share it with your healthcare team.

By comparing this new remote monitoring system to the usual care provided in clinics, the researchers hope to show that it's a safe and cost-effective way to look after people with pacemakers. This could mean fewer trips to the hospital for routine checks, giving you more flexibility and convenience.

Key takeaways

This study explores a new way to monitor pacemakers remotely from home.
It compares remote monitoring to regular in-clinic hospital visits.
The goal is to make pacemaker follow-up more convenient and potentially affordable.
Participants will use a special online system called VIRTUES.
You will be randomly assigned to either the remote or standard care group.
You can stop participating in the study at any time.

Who may be eligible?

To be part of this study, you need to have a Medtronic or Abbott pacemaker that is able to send information remotely. You also need to be at least 18 years old and be able to understand and agree to take part in the study.

There are a few reasons why you might not be able to join. For example, if you don't have a family doctor, or if you're already in a similar pacemaker study, you wouldn't be able to participate. Also, if your pacemaker relies heavily on a feature called 'automated capture verification' and that feature isn't working reliably, you wouldn't be able to join.

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.

Do you have a Medtronic or Abbott brand pacemaker?
Is your pacemaker capable of sending information remotely?
Are you 18 years old or older?
Do you have a family doctor?
Are you able to provide consent to take part in the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly put into one of two groups. One group will receive 'remote patient management', and the other will receive 'standard care'.

If you're in the remote patient management group, your pacemaker will mainly be monitored remotely from your home. This means you won't have routine in-clinic visits. Instead, your pacemaker will send information every six months. If there's anything unusual or that needs attention, you'll then be asked to come into a nearby clinic. After your pacemaker is first put in, you might have one or two in-person checks to make sure everything is set up correctly for remote monitoring. You'll also get access to an online portal where you can see information about your pacemaker. This portal also allows your care team to check things outside of normal hours if needed.

If you're in the standard care group, you'll have regular in-clinic appointments, usually once a year, just like current practice. You wouldn't use the special virtual system or have your pacemaker monitored remotely in the same way as the other group. For all patients in the study, your pacemaker will be programmed in a specific way to help monitor certain heart activities.

Potential risks and benefits

Taking part in this study might offer some potential benefits, such as fewer trips to the hospital for routine check-ups and more convenience in managing your pacemaker. You might also gain more insight into your own health data through the special online portal. As with any study, there could be some risks. While remote monitoring is generally considered safe, there might be a chance that a less common issue with your pacemaker could be identified slightly later compared to a direct clinic visit. The study is designed to assess if remote-only follow-up, with clinic visits as needed, is safe. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

Foothills Hospital
Verified postcode
Calgary, Canada
Victoria Cardiac Arrhythmia Trials
Verified postcode
Victoria, Canada
Memorial University of Newfoundland Hospital
Verified postcode
St. John's, Canada
QEII Health Sciences Center
Verified postcode
Halifax, Canada
St. Mary's General Hospital
Verified postcode
Kitchener, Canada
London Health Sciences Centre
Verified postcode
London, Canada
Southlake Regional Health Centre
Verified postcode
Newmarket, Canada
Montreal Heart Institute
Verified postcode
Montreal, Canada
Hopital Sacre Coeur
Verified postcode
Montreal, Canada
Hopital Laval
Verified postcode
Québec, Canada
Centre Hospitalier Universitaire du Sherbrooke
Verified postcode
Sherbrooke, Canada

Common questions

What is remote monitoring for a pacemaker?

Remote monitoring means your pacemaker can send information to your doctors from your home, so you don't always have to go to the hospital for checks.

Will I still see a doctor if I'm in the remote monitoring group?

Yes, if an issue is detected by remote monitoring, or if it's necessary after your pacemaker is first implanted, you will still see a doctor or nurse at a clinic.

What is the VIRTUES system?

VIRTUES is an online portal that lets you see information about your pacemaker and helps your healthcare team manage your care remotely.

How long will the study last?

The study description doesn't specify an exact duration for each patient, but monitoring will occur at regular intervals.

Can I choose which group I'm in?

No, you will be randomly assigned to either the remote monitoring group or the standard care group, much like flipping a coin, to ensure a fair comparison.