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RECRUITING
NCT03636230
NA

Remote Patient Management of CIEDs - Brady Devices

Sponsor: Ratika Parkash

View on ClinicalTrials.gov

Summary

While remote monitoring (RM) technology is currently available and has permitted surveillance and device assessment from any patient location, the use has been inconsistent in Canada, where only 8500 out of a potential 120 000 patients with cardiac implantable electronic devices (CIEDs) are enrolled in this program. This technology is in widespread use worldwide for all CIEDs but in Canada, it is utilized primarily for implantable defibrillators, but not pacemakers. Whereas most of the trials were designed to evaluate the efficacy of RM in implantable cardioverter defibrillator (ICD) patients, in the pacemaker (PM) population, there has been work performed already to demonstrate an increase in detection of frequency of adverse clinical events and a reduction in reaction time to those events by RM. Based on all the available literature, it appears that RM benefits both patients and healthcare systems. Overall, studies have demonstrated that RM can be used safely in all device patient-populations, with the exception of pacemaker-dependent patients. There have been no studies that have evaluated RM only follow up, nor have there been any studies evaluating pacemaker-dependent patients. This study that will safely assess the use of RM only, with in-clinic visits when necessary, that uses the patient-centered electronic platform developed by the Cardiac Arrhythmia Network of Canada (CANet) to perform PM follow up safely, in a more cost-effective manner.

Official title: Remote Patient Management of Cardiac Implantable Electronic Devices - Brady Devices

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

848

Start Date

2020-09-15

Completion Date

2025-06-30

Last Updated

2025-02-13

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Remote Monitoring

Remote Monitoring only + VIRTUES

OTHER

Standard of care

In-Clinic visits only

Locations (11)

Foothills Hospital

Calgary, Alberta, Canada

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, Canada

Memorial University of Newfoundland Hospital

St. John's, Newfoundland and Labrador, Canada

QEII Health Sciences Center

Halifax, Nova Scotia, Canada

St. Mary's General Hospital

Kitchener, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Hopital Sacre Coeur

Montreal, Quebec, Canada

Hopital Laval

Québec, Quebec, Canada

Centre Hospitalier Universitaire du Sherbrooke

Sherbrooke, Quebec, Canada