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REMOTE-IPG: REmote MOnitoring Transmission Evaluation of IPGs

Sponsor
Medtronic Cardiac Rhythm and Heart Failure (Industry)
Overall Status
Completed
CT.gov ID
NCT00631709
Collaborator
(none)
120
Enrollment
3
Locations
1
Arm
23.1
Duration (Months)
40
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: CareLink Remote Monitoring
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
REmote MOnitoring Transmission Evaluation of IPGs
Study Start Date :
Mar 1, 2008
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Feb 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kelowna General Hospital Kelowna British Columbia Canada
    2 Southlake Regional Hospital Newmarket Ontario Canada
    3 CHUQ, L'Hotel Dieu de Quebec Quebec City Quebec Canada

    Sponsors and Collaborators

    • Medtronic Cardiac Rhythm and Heart Failure

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic Cardiac Rhythm and Heart Failure
    ClinicalTrials.gov Identifier:
    NCT00631709
    Other Study ID Numbers:
    • REMOTE-IPG 2008
    First Posted:
    Mar 10, 2008
    Last Update Posted:
    Apr 26, 2018
    Last Verified:
    Apr 1, 2018

    Study Results

    No Results Posted as of Apr 26, 2018