Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03636230

Remote Patient Management of CIEDs - Brady Devices

Led by Ratika Parkash · Updated on 2025-02-13

848

Participants Needed

11

Research Sites

249 weeks

Total Duration

On this page

Sponsors

R

Ratika Parkash

Lead Sponsor

C

Cardiac Arrhythmia Network of Canada

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Remote Patient Management of CIEDs - Brady Devices

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a Medtronic or Abbott pacemaker capable of remote monitoring.
  • Able to provide consent.
  • Age �3D 18 years
Not Eligible

You will not qualify if you...

  • No access to a family physician or general practitioner.
  • Participation in the RPM CIED pilot study.
  • Unreliable automated capture verification function by the device in pacemaker-dependent patients.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 11 locations

1

Foothills Hospital

Calgary, Alberta, Canada, T2N 4Z6

Actively Recruiting

2

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, Canada, V8T 1Z8

Actively Recruiting

3

Memorial University of Newfoundland Hospital

St. John's, Newfoundland and Labrador, Canada

Actively Recruiting

4

QEII Health Sciences Center

Halifax, Nova Scotia, Canada, B3H 3A7

Actively Recruiting

5

St. Mary's General Hospital

Kitchener, Ontario, Canada

Actively Recruiting

6

London Health Sciences Centre

London, Ontario, Canada, N6A 5W5

Actively Recruiting

7

Southlake Regional Health Centre

Newmarket, Ontario, Canada, L3Y 2P9

Actively Recruiting

8

Montreal Heart Institute

Montreal, Quebec, Canada, H1T 1C8

Actively Recruiting

9

Hopital Sacre Coeur

Montreal, Quebec, Canada

Actively Recruiting

10

Hopital Laval

Québec, Quebec, Canada

Actively Recruiting

11

Centre Hospitalier Universitaire du Sherbrooke

Sherbrooke, Quebec, Canada, J1H 5N4

Actively Recruiting

Loading map...

Research Team

R

Ratika Parkash, MD FRCPC

CONTACT

P

Patricia Theoret

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here