REmote MOnitoring Transmission Evaluation of IPGs (REMOTE-IPG)

April 24, 2018 updated by: Medtronic Cardiac Rhythm and Heart Failure

The purpose of this study is to evaluate the potential clinical and economic benefits of using CareLink remote management for pacemaker follow-up.

Study Objectives include:

  1. To determine clinician perceived quality of care for CareLink remote follow-up.
  2. To determine patient satisfaction with CareLink follow-up.
  3. To estimate the time required to perform patient follow-up via CareLink remote transmissions.
  4. To determine the percentage of regular CareLink follow-ups that do not require further in-clinic review of the patient.
  5. To estimate potential patient cost avoidance for one year of follow up incorporating CareLink.
  6. To evaluate compliance to scheduled CareLink transmissions with the remote management system

This is a non-randomized, multi-center, prospective study in which 120 patients who have a pacemaker are enrolled into the study and receive a CareLink monitor. Patients will replace their regularly scheduled pacemaker clinic follow-up visits with a CareLink remote transmission for 12months.

Patients will require a test transmission within 1 month after they receive their CareLink monitor. Afterwards, patients are followed via CareLink transmissions as per their usual clinic schedule for 12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Kelowna General Hospital
    • Ontario
      • Newmarket, Ontario, Canada
        • Southlake Regional Hospital
    • Quebec
      • Quebec City, Quebec, Canada
        • CHUQ, L'Hotel Dieu de Quebec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have received a market released Medtronic pacemaker with automatic threshold management features for all active leads.
  • Patients who have been implanted with their current pacemaker for at least 3 months.
  • Patients who are willing, or who have caregivers willing, to use the Medtronic CareLink Monitor.
  • Patients who are willing and able to sign an IRB/MEC approved patient informed consent.

Exclusion Criteria:

  • Patients participating in another study that would affect the objectives of this study
  • Patients who have already previously used a Medtronic CareLink Monitor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Pacemaker Patients
Other: CareLink Remote Monitoring
Substitution of CareLink Remote Monitoring of Pacemakers for in-clinic pacemaker follow-up visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

March 3, 2008

First Submitted That Met QC Criteria

March 3, 2008

First Posted (Estimate)

March 10, 2008

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • REMOTE-IPG 2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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