Remote Patient Management for Cardiac Implantable Electronic Devices

Arrhythmia, Cardiac Clinical Trial

— RPM-CIED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585817
• Other study ID #: RP-002
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: April 2019

Study information

• Verified date: April 2019
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: April 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmia, Cardiac
• Arrhythmias, Cardiac

Intervention

Device:
• Remote CIED Management
Information Technology

Locations

Country	Name	City	State
Canada	QEII HSC	Halifax	Nova Scotia

Sponsors (3)

Lead Sponsor	Collaborator
Ratika Parkash	Cardiac Arrhythmia Network of Canada, Medtronic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility: Feasibility will be measured by the time to implement a fully functioning system at the participating centers		6 months
Secondary	Compliance (number of received remote transmissions divided by the number of expected remote transmissions)	Compliance to remote patient management will be measured for patients by the number of received remote transmissions divided by the number of expected remote transmissions.	12 months