REmote MOnitoring Transmission Evaluation of IPGs

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00631709

Acronym

REMOTE-IPG

Enrollment

120

Registered

2008-03-10

Start date

2008-03-31

Completion date

2010-02-28

Last updated

2018-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pacemaker

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.

Interventions

OTHERCareLink Remote Monitoring

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026