Clinical trial NCT03636230: Remote Patient Management of CIEDs - Brady Devices
Official title: Remote Patient Management of Cardiac Implantable Electronic Devices - Brady Devices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pacemaker
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Cardiac Arrhythmia Network of Canada
name: Medtronic
name: Abbott
First posted: 2018-08-17
Enrollment: 848
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label, 1:1 randomized trial, stratified by site and pacemaker dependence
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a Canadian multicenter randomized controlled trial to assess remote patient management. Patients will be randomized in a 1:1 fashion, stratified by pacemaker dependence and by center to either remote patient management of standard of care.

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.

Eligibility 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

Primary outcomes:
measure: Time to major adverse cardiac event (primary safety outcome)
timeFrame: 18 months
measure: Cost effectiveness
timeFrame: 18 months
Secondary outcomes:
measure: Quality of Life - Short Form (SF36)
timeFrame: 18 months
measure: Quality of Life - Florida Patient Acceptance Survey (FPAS)
timeFrame: 18 months
measure: Quality of Life - Florida Shock Anxiety Scale (FSAS)
timeFrame: 18 months
measure: Quality of Life - Brief Illness Perception Questionnaire (BIPQ)
timeFrame: 18 months
measure: Device-related ER visits
timeFrame: 18 months
measure: Syncope
timeFrame: 18 months
measure: Time to detection of ventricular arrhythmia events
timeFrame: 18 months
measure: Atrial fibrillation
timeFrame: 18 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
city: Victoria
country: Canada
facility: Victoria Cardiac Arrhythmia Trials
state: British Columbia
city: Saint John's
country: Canada
facility: Memorial University of Newfoundland Hospital
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: QEII Health Sciences Center
state: Nova Scotia
city: Kitchener
country: Canada
facility: St. Mary's General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montréal
country: Canada
facility: Hopital Sacre Coeur
state: Quebec
city: Quebec City
country: Canada
facility: Hopital Laval
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire du Sherbrooke
state: Quebec
Study officials:
affiliation: Nova Scotia Health Authority
name: Ratika Parkash, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: