Clinical trial NCT03405740: Remote Patient Management of CIEDs
Official title: Remote Patient Management of Cardiac Implantable Electronic Devices - Tachy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Arrhythmia
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Cardiac Arrhythmia Network of Canada
name: Abbott Medical Devices
name: Medtronic
First posted: 2018-01-23
Enrollment: 1164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 stratified by RemoteView vs no RemoteView utilization, as well as by center.

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 follow up. In this study, we propose a paradigm shift in CIED follow up care that is fully remote, supported by a patient-centered communication system permitting patients to have greater understanding of their CIED and its function. Patients would not have to leave their own communities to obtain state-of-the art care for their cardiac condition or their CIED. Given the burgeoning use of CIEDs (ICDs and PMs), the aging population and particularly in Canada where 19% of the inhabitants are in communities classified as 'rural', many have long distances to travel to reach a health care facility, it is of the utmost importance to take full advantage of available and developing technologies to improve CIED follow up beyond current recommendations. During the life of these patients, many issues may arise, such as atrial or ventricular arrhythmias that may result in syncope, stroke or sudden death, need for increased monitoring resulting from device advisories, or minor programming adjustments to improve device performance, or simply the need for enhanced surveillance as the device battery depletes and replacement is anticipated. New technology has become available that not only permits surveillance, but also permits communication back to the patient, and their respective providers regarding the status of these devices. The combination of technologies will result in a total care of CIEDs termed Remote Patient Management - CIED (RPM-CIED). The incorporation of enhanced monitoring capability, along with automatic recalibration of device settings, allows us to develop a new paradigm of remote patient management where after the patient receives their device, they would remain in the care of their local health team ('spokes') and no longer require travel to the specialized device clinics ('hubs') for follow-up. It creates capacity in the specialized centers to focus exclusively on the problematic cases by removing the need for routine checks.

There are two avenues of new technology that will be used in this study:

1. Remote View: this secure, web-based portal facilitates a virtual view of the device programming by the specialist in real-time while the patient is in their local clinic, thus avoiding patient travel to the specialized clinic (hub).
2. VIRTUES (Virtual Integrated Reliable Transformative User-driven E-health System): this portal has been developed by the Cardiac Arrhythmia Network of Canada to allow the patient to receive reports from the remote transmissions of their device.

Eligibility criteria: Inclusion Criteria:

1. Patients with a Medtronic, Abbott or Boston Scientific defibrillator/CRT-D capable of remote monitoring with Carelink, Merlin or Latitude.
2. Able to provide consent.
3. Age \>/= 18 years

Exclusion Criteria:

1. No family physician or general practitioner
2. Inability to be referred to a specialist
3. Currently followed more than every 6 months by a Heart Function Clinic
4. Participation in another randomized clinical trial that impacts outcome
5. Unreliable automated capture verification by device in pacemaker dependent patient

Primary outcomes:
measure: Time to major adverse cardiac event (primary safety outcome)
timeFrame: 18 months
measure: Time to a device-detected event (primary efficacy outcome)
timeFrame: 18 months
Secondary outcomes:
measure: Medication Compliance
timeFrame: 18 Months
measure: Minimum programming compliance
timeFrame: 18 months
measure: Number of clinical events leading to a change in medication
timeFrame: 18 months
measure: Inappropriate ICD shocks
timeFrame: 18 months
measure: Appropriate ICD shocks
timeFrame: 18 months
measure: Time to detection of ventricular arrhythmia events
timeFrame: 18 months
measure: Detection of atrial high-rate episodes
timeFrame: 18 months
measure: Number of Cardiovascular-related ER visits
timeFrame: 18 months
measure: Number of Device-Related ER visits
timeFrame: 18 Months
measure: Rate of syncope
timeFrame: 18 months
measure: Cost effectiveness
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: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: Halifax
country: Canada
facility: QEII HSC
state: Nova Scotia
city: Kitchener
country: Canada
facility: St. Mary's General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: Hopital SacreCoeur
state: Quebec
city: Québec
country: Canada
facility: Hopital Laval
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Nova Scotia Health Authority
name: Ratika Parkash, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: