Remote Patient Management for Cardiac Implantable Electronic Devices

NCT02585817 | Completed

• 1 other identifier: RP-002
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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. 1.Long, expensive travel for patients
2. 2.Morbidity to patients due to delay in receiving appropriate treatment
3. 3.Efficiency in health care delivery
4. 4.Patient satisfaction

Conditions

Arrhythmia, Cardiac

Keywords

Cardiac Implantable Electronic Devices

Outcome Measures

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.

  6 months

Secondary Outcomes (2)

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

  6 months

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

  12 months

Study Arms (1)

Remote CIED Management

EXPERIMENTAL

Patients with a CIED will undergo remote monitoring with information technology.

Device: Remote CIED Management

Interventions

Remote CIED Management DEVICE

Information Technology

Remote CIED Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Ratika Parkash: lead
• Cardiac Arrhythmia Network of Canada: collaborator
• Medtronic: collaborator

Study Sites (1)

QEII HSC

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Related Publications (1)

• Sapp JA, Gillis AM, AbdelWahab A, Nault I, Nery PB, Healey JS, Raj SR, Lockwood E, Sterns LD, Sears SF, Wells GA, Yee R, Philippon F, Tang A, Parkash R. Remote-only monitoring for patients with cardiac implantable electronic devices: a before-and-after pilot study. CMAJ Open. 2021 Jan 25;9(1):E53-E61. doi: 10.9778/cmajo.20200041. Print 2021 Jan-Mar.

  PMID: 33495385 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ratika Parkash, MD, FRCPC

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Cardiologist

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 23, 2015
• Study Start: October 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: April 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)