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OpenTrials
Completed

NCT Number: NCT02585817

Remote Patient Management for Cardiac Implantable Electronic Devices

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

QEII HSC

Halifax, Nova Scotia, B3H 3A7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Able to provide consent.

Treatment and study plan

Remote CIED Management

Device

Information Technology

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. Feasibility: Feasibility will be measured by the time to implement a fully functioning system at the participating centers

    Time frame: 6 months

  2. Compliance (number of received remote transmissions divided by the number of expected remote transmissions)

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Ratika Parkash

Other

Collaborators

  • Cardiac Arrhythmia Network of Canada
  • Medtronic

Registry information

Official study title

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

Acronym: RPM-CIED

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 23, 2015
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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