Remote Patient Management of CIEDs
- Conditions
- Cardiac Arrhythmia
- Interventions
- Device: Remote Patient ManagementDevice: Standard of Care
- Registration Number
- NCT03405740
- Lead Sponsor
- Ratika Parkash
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1164
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Remote Patient Management Remote Patient Management Patients will be followed by remote monitoring only. Standard of Care Standard of Care Remote monitoring at 6 month intervals, alternating with yearly in-clinic visits at their usual site.
- Primary Outcome Measures
Name Time Method Time to major adverse cardiac event (primary safety outcome) 18 months Time to a major adverse event, including: death, stroke, hospitalization for complications relating to the device system, cardiovascular hospitalization, syncope, device-related Emergency Department visits.
Time to a device-detected event (primary efficacy outcome) 18 months The response time from a clinical event to a clinical decision in response to arrhythmias, cardiovascular disease progression, and device issues with remote patient management as compared to standard of care
- Secondary Outcome Measures
Name Time Method Medication Compliance 18 Months Compliance will be measured according to current Canadian Cardiovascular Society Heart Failure Guidelines
Minimum programming compliance 18 months Minimum ICD programming according to Canadian Heart Rhythm Society programming recommendations
Number of clinical events leading to a change in medication 18 months Events detected by the ICD that lead to a clinical decision to change medication
Inappropriate ICD shocks 18 months Number of inappropriate ICD shocks
Appropriate ICD shocks 18 months Number of appropriate ICD shocks
Time to detection of ventricular arrhythmia events 18 months device-detected ventricular fibrillation or ventricular tachycardia
Detection of atrial high-rate episodes 18 months Device detected high-rate episodes greater than 6 minutes
Number of Cardiovascular-related ER visits 18 months Number of cardiovascular-related visits (\<24 hours)
Number of Device-Related ER visits 18 Months ER visits (\<24 hrs) for a device-related reason (including an audio signal from the device (beeping), shock(s), or a device complication requiring medical attention)
Rate of syncope 18 months Syncope
Cost effectiveness 18 months An economic evaluation will include a cost utility analysis
Trial Locations
- Locations (12)
Foothills Hospital
🇨🇦Calgary, Alberta, Canada
Victoria Cardiac Arrhythmia Trials
🇨🇦Victoria, British Columbia, Canada
St. Boniface Hospital
🇨🇦Winnipeg, Manitoba, Canada
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
QEII HSC
🇨🇦Halifax, Nova Scotia, Canada
St. Mary's General Hospital
🇨🇦Kitchener, Ontario, Canada
London Health Sciences Center
🇨🇦London, Ontario, Canada
Southlake Regional Health Centre
🇨🇦Newmarket, Ontario, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
Hopital SacreCoeur
🇨🇦Montreal, Quebec, Canada
Hopital Laval
🇨🇦Québec, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada