REmote MOnitoring Transmission Evaluation of IPGs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Pacemaker

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Pacemaker Patients

Group Type EXPERIMENTAL

CareLink Remote Monitoring

Intervention Type OTHER

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

Interventions

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CareLink Remote Monitoring

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

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No