Remote management of pacemakers using technology
Remote Patient Management of Cardiac Implantable Electronic Devices - Brady Devices
This study tests if using a web-based tool to manage pacemakers from home can help patients stay healthier and cut down on trips to the clinic.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 848 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Locations | 11 sites (Calgary, Alberta and 10 other locations) |
| Trial ID | NCT03636230 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of remote patient management for individuals with pacemakers, aiming to improve monitoring and reduce the need for in-clinic visits. Patients will be randomly assigned to either remote monitoring or standard care, with remote transmissions occurring every six months. The intervention group will utilize a web-based portal called VIRTUES to access their health data and receive real-time updates on their device status. The study seeks to demonstrate that remote management can enhance patient outcomes and streamline healthcare delivery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a Medtronic or Abbott pacemaker capable of remote monitoring.
Not a fit: Patients without access to a family physician or those participating in the RPM CIED pilot study may not benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could lead to improved patient monitoring and quicker responses to adverse events for those with pacemakers.
How similar studies have performed: Previous studies have shown that remote monitoring can be beneficial for patients with cardiac implantable electronic devices, suggesting a positive outlook for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Calgary, Alberta and 10 other locations
- Foothills Hospital — Calgary, Alberta, Canada (Recruiting)
- Victoria Cardiac Arrhythmia Trials — Victoria, British Columbia, Canada (Recruiting)
- Memorial University of Newfoundland Hospital — St. John's, Newfoundland and Labrador, Canada (Recruiting)
- QEII Health Sciences Center — Halifax, Nova Scotia, Canada (Recruiting)
- St. Mary's General Hospital — Kitchener, Ontario, Canada (Recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- Southlake Regional Health Centre — Newmarket, Ontario, Canada (Recruiting)
- Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)
- Hopital Sacre Coeur — Montreal, Quebec, Canada (Recruiting)
- Hopital Laval — Québec, Quebec, Canada (Recruiting)
- Centre Hospitalier Universitaire du Sherbrooke — Sherbrooke, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Ratika Parkash, MD FRCPC — Nova Scotia Health Authority
- Study coordinator: Ratika Parkash, MD FRCPC
- Email: ratika.parkash@nshealth.ca
- Phone: 902 473 4474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.