REmote MOnitoring Transmission Evaluation of IPGs

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pacemaker

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kelowna General Hospital, Kelowna, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CareLink Remote Monitoring

Other

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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Acronym: REMOTE-IPG

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2010
First posted: Mar 10, 2008
Registry last updated: Apr 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed