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REmote MOnitoring Transmission Evaluation of IPGs

NCT00631709 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-04-26

No results posted yet for this study

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.

Conditions

  • Pacemaker

Interventions

OTHER

CareLink Remote Monitoring

Substitution of CareLink Remote Monitoring of Pacemakers for in-clinic pacemaker follow-up visits

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-11-30
Completion
2010-02-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00631709 on ClinicalTrials.gov