Remote Patient Management of Cardiac Implantable Electronic Devices - Tachy
Overview
- Phase
- Not Applicable
- Intervention
- Remote Patient Management
- Conditions
- Cardiac Arrhythmia
- Sponsor
- Ratika Parkash
- Enrollment
- 1115
- Locations
- 12
- Primary Endpoint
- Time to major adverse cardiac event (primary safety outcome)
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Ratika Parkash
Staff Electrophysiologist
Nova Scotia Health Authority
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Remote Patient Management
Patients will be followed by remote monitoring only.
Intervention: Remote Patient Management
Standard of Care
Remote monitoring at 6 month intervals, alternating with yearly in-clinic visits at their usual site.
Intervention: Standard of Care
Outcomes
Primary Outcomes
Time to major adverse cardiac event (primary safety outcome)
Time Frame: 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)
Time Frame: 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 Outcomes
- Medication Compliance(18 Months)
- Minimum programming compliance(18 months)
- Number of clinical events leading to a change in medication(18 months)
- Inappropriate ICD shocks(18 months)
- Appropriate ICD shocks(18 months)
- Time to detection of ventricular arrhythmia events(18 months)
- Detection of atrial high-rate episodes(18 months)
- Number of Cardiovascular-related ER visits(18 months)
- Number of Device-Related ER visits(18 Months)
- Rate of syncope(18 months)
- Cost effectiveness(18 months)