Remote Patient Management of CIEDs

Study Overview
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Brief Summary
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This is a Canadian multicenter randomized controlled trial to assess remote patient management. Patients will be randomized to remote patient management versus usual care, and will be stratified by RemoteView vs no RemoteView utilization, as well as by center.

Detailed Description
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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: 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). 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.

Official Title
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Remote Patient Management of Cardiac Implantable Electronic Devices - Tachy

Conditions
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Cardiac Arrhythmia

Intervention / Treatment
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* Device: Remote Patient Management
* Device: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medtronic or Abbott defibrillator (ICD or CRT-D) capable of remote monitoring with Carelink/Merlin Able to provide consent Exclusion Criteria: No family physician 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 Unreliable autocapture by device in pacemaker dependent patient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remote Patient Management<br>Patients will be followed by remote monitoring only. | Device: Remote Patient Management<br>* 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 clinic. All patients will be required to follow up with their family physician at least annually, and their cardiologist at least every 2 years. Patients will be contacted by phone at 6 months and 12 months to document their current health status (change in cardiovascular medications, any cardiovascular hospitalizations, in-clinic device checks, or any new cardiovascular testing completed since the last visit) VIRTUES access<br>|
| Placebo Comparator: Standard of Care<br>Remote monitoring at 6 month intervals, alternating with yearly in-clinic visits at their usual site. | Device: Standard of Care<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to major adverse cardiac event (primary safety outcome) | 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. | 18 months | 
| Time to a device-detected event | 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 | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to detection of ventricular arrhythmia events | device-detected ventricular fibrillation or ventricular tachycardia | 18 months | 
| Detection of atrial fibrillation episodes | Device detected episodes of atrial fibrillation | 18 months | 
| Atrial fibrillation related hospitalizations | Hospitalization with a primary diagnosis of atrial fibrillation | 18 months | 
| Time to syncope | Syncope | 18 months | 
| Cost effectiveness | An economic evaluation will include a cost utility analysis | 18 months |