Remote Patient Management of CIEDs

Cardiac Arrhythmia Clinical Trial

— RPM CIED Tachy  

Official title:

Remote Patient Management of Cardiac Implantable Electronic Devices - Tachy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03405740
• Other study ID #: RP005
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: March 2025

Study information

• Verified date: March 2023
• Source: Nova Scotia Health Authority
• Contact: Ratika Parkash, MD FRCPC
• Phone: 902 473 4474
• Email: ratika.parkash[@]nshealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 2554
• Est. completion date: March 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

Device:
• Remote Patient Management
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
• Standard of Care
No intervention

Locations

Country	Name	City	State
Canada	Foothills Hospital	Calgary	Alberta
Canada	QEII HSC	Halifax	Nova Scotia
Canada	St. Mary's General Hospital	Kitchener	Ontario
Canada	London Health Sciences Center	London	Ontario
Canada	Hopital SacreCoeur	Montreal	Quebec
Canada	Hopital Laval	Québec	Quebec
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	St. Boniface Hospital	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Ratika Parkash	Cardiac Arrhythmia Network of Canada

Country where clinical trial is conducted

Canada, 

Outcome

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