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Remote Patient Management for Cardiac Implantable Electronic Devices (RPM-CIED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02585817
Recruitment Status : Completed
First Posted : October 23, 2015
Last Update Posted : April 25, 2019
Sponsor:
Collaborators:
Cardiac Arrhythmia Network of Canada
Medtronic
Information provided by (Responsible Party):
Ratika Parkash, Nova Scotia Health Authority

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

Condition or disease Intervention/treatment Phase
Arrhythmia, Cardiac Device: Remote CIED Management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Remote Patient Management for Cardiac Implantable Electronic Devices - A Pilot Study
Actual Study Start Date : October 2016
Actual Primary Completion Date : March 2019
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

Arm Intervention/treatment
Experimental: Remote CIED Management
Patients with a CIED will undergo remote monitoring with information technology.
Device: Remote CIED Management
Information Technology




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585817


Locations
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Canada, Nova Scotia
QEII HSC
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Ratika Parkash
Cardiac Arrhythmia Network of Canada
Medtronic
Investigators
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Principal Investigator: Ratika Parkash, MD, FRCPC Nova Scotia Health Authority
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Responsible Party: Ratika Parkash, Staff Cardiologist, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02585817    
Other Study ID Numbers: RP-002
First Posted: October 23, 2015    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ratika Parkash, Nova Scotia Health Authority:
Cardiac Implantable Electronic Devices
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes