Status:
RECRUITING
Remote Patient Management of CIEDs
Lead Sponsor:
Ratika Parkash
Collaborating Sponsors:
Cardiac Arrhythmia Network of Canada
Abbott Medical Devices
Conditions:
Cardiac Arrhythmia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a Canadian multicenter randomized controlled trial to assess remote patient management. Patients will be randomized to remote patient management with VIRTUES versus usual care, and will be str...
Detailed Description
Remote monitoring (RM) has been in use for over a decade and is now used in a blended system of in clinic visits and RM to provide CIED follow up. Prior studies have focused on this blended model of f...
Eligibility Criteria
Inclusion
- Patients with a Medtronic, Abbott or Boston Scientific defibrillator/CRT-D capable of remote monitoring with Carelink, Merlin or Latitude.
- Able to provide consent.
- Age \>/= 18 years
Exclusion
- No family physician or general practitioner
- Inability to be referred to a specialist
- Currently followed more than every 6 months by a Heart Function Clinic
- Participation in another randomized clinical trial that impacts outcome
- Unreliable automated capture verification by device in pacemaker dependent patient
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
1164 Patients enrolled
Trial Details
Trial ID
NCT03405740
Start Date
May 1 2020
End Date
June 30 2025
Last Update
February 13 2025
Active Locations (12)
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1
Foothills Hospital
Calgary, Alberta, Canada
2
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, Canada, V8Z 0B9
3
St. Boniface Hospital
Winnipeg, Manitoba, Canada
4
Saint John Regional Hospital
Saint John, New Brunswick, Canada