Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
848 participants
INTERVENTIONAL
2020-09-15
2025-06-30
Brief Summary
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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.
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Detailed Description
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Remote patient management (intervention group):
* Patients will be followed by remote monitoring only. Transmissions will occur at six monthly intervals, with no in-clinic visits. If there is an actionable event on the remote transmission, patients will be seen at their closest community device clinic. The proposed intervention would eliminate any routine visits.
* Newly implanted pacemaker patients will be seen after the initial implant at the hub site, within 48 hours and then within 3 months to optimize programming for subsequent RM visits. Thereafter, all follow-up will occur through remote monitoring every six months. Unscheduled remote transmissions may also occur. Using a combination of remote monitoring, and novel technology, VIRTUES, patients will be managed outside of the clinic.
* Patients will be provided with real-time knowledge of success of their remote transmission and the status of the remote through a web-based portal called VIRTUES.
* Virtual patient record - all patient information in the intervention arm will be contained within an information cloud that will be accessible by patients; access to their own data may be granted by the patient themselves to permit delivery of care remotely, and to permit after hours follow up to be performed by the on call personnel.
Standard of care (comparison group):
The standard arm will be required to have in-clinic visits at yearly intervals. These patients would not have access to the virtual patient cloud or to remote monitoring.
Pacemaker programming: All patients in both arms will undergo programming as per the ASSERT II protocol (previously published) to optimize pacemaker parameters and detection of atrial and ventricular high rate episodes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Remote Patient Management
Remote monitoring only
Remote Monitoring
Remote Monitoring only + VIRTUES
Standard of Care
In-clinic visits
Standard of care
In-Clinic visits only
Interventions
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Remote Monitoring
Remote Monitoring only + VIRTUES
Standard of care
In-Clinic visits only
Eligibility Criteria
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Inclusion Criteria
* Able to provide consent.
* Age \>/= 18 years
Exclusion Criteria
* Participation in the RPM CIED pilot study
* Unreliable automated capture verification function by the device in pacemaker-dependent patients
18 Years
ALL
No
Sponsors
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Cardiac Arrhythmia Network of Canada
OTHER
Medtronic
INDUSTRY
Abbott
INDUSTRY
Ratika Parkash
OTHER
Responsible Party
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Ratika Parkash
Staff Cardiologist Electrophysiologist
Principal Investigators
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Ratika Parkash, MD FRCPC
Role: PRINCIPAL_INVESTIGATOR
Nova Scotia Health Authority
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Marcello Tonelli
Role: primary
May Woodburn
Role: primary
Ashley Hunt
Role: primary
Ashley Hilchie
Role: primary
Mary Radyk
Role: primary
Cheryl Litchfield
Role: primary
Brigitte Boaretto
Role: primary
Jean-Claude Tardif
Role: primary
Ann Langlois
Role: primary
Paule Banville
Role: primary
William Fraser
Role: primary
Other Identifiers
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RP-006
Identifier Type: -
Identifier Source: org_study_id
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