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Remote Patient Management for Cardiac Implantable Electronic Devices

Remote Patient Management for Cardiac Implantable Electronic Devices - A Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02585817
Acronym
RPM-CIED
Enrollment
176
Registered
2015-10-23
Start date
2016-10-31
Completion date
2019-04-30
Last updated
2019-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia, Cardiac

Keywords

Cardiac Implantable Electronic Devices

Brief summary

This is a pilot study to assess barriers, evaluate and implement a patient oriented CIED management model incorporating advanced technological innovation to promote a paradigm shift to patient-centered care involving remote CIED monitoring and programming. The advancement in technology is very important as it addresses several potential gaps and barriers in the care of patients with CIEDS: 1. Long, expensive travel for patients 2. Morbidity to patients due to delay in receiving appropriate treatment 3. Efficiency in health care delivery 4. Patient satisfaction

Detailed description

Canada is a country with a diverse geography, of which 19% of the inhabitants are in communities classified as 'rural', but many may still have long distances to travel to reach a health care facility. This results in challenges in uniform delivery of health care throughout the country. There are 25,000 pacemaker (PM) implants and 7000 implantable defibrillator (ICD) implants yearly in Canada, with approximately 120 000 patients living with these devices. The recommended follow-up for these devices are based on consensus and position statements, with the majority of patients requiring at least yearly visits to a specialized device clinic during the lifetime of their device. 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. While remote monitoring technology is currently available and has permitted surveillance and device assessment from any patient location accessible to a landline or mobile phone, the use has been inconsistent in Canada. In addition, new technology has become available that not only permits surveillance, but also remote programming of these devices. The incorporation of remote programming 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 and no longer require travel to the specialized 'hub' clinics for follow-up.

Interventions

DEVICERemote CIED Management

Information Technology

Sponsors

Cardiac Arrhythmia Network of Canada
CollaboratorOTHER
Medtronic
CollaboratorINDUSTRY
Ratika Parkash
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients with an implanted pacemaker/cardiac resynchronization therapy with a pacemaker(CRT-P) capable of remote patient management would be eligible for the study that will be followed by the site where the implantation occurred OR patients with an implanted defibrillator/CRT-D capable of remote patient management where the patients reside in a community OUTSIDE of the site where the implantation occurred. The device may be de novo, existing or a patient undergoing a pulse generator change that now has remote patient management capabilities. 2. Able to provide consent.

Design outcomes

Primary

MeasureTime frame
Generalizability: Measurement of generalizability will be done by measuring the number of patients eligible for remote patient management as a proportion of all CIED patients.6 months

Secondary

MeasureTime frameDescription
Feasibility: Feasibility will be measured by the time to implement a fully functioning system at the participating centers6 months
Compliance (number of received remote transmissions divided by the number of expected remote transmissions)12 monthsCompliance to remote patient management will be measured for patients by the number of received remote transmissions divided by the number of expected remote transmissions.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026