REmote MOnitoring Transmission Evaluation of IPGs (REMOTE-IPG)
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:
- To determine clinician perceived quality of care for CareLink remote follow-up.
- To determine patient satisfaction with CareLink follow-up.
- To estimate the time required to perform patient follow-up via CareLink remote transmissions.
- To determine the percentage of regular CareLink follow-ups that do not require further in-clinic review of the patient.
- To estimate potential patient cost avoidance for one year of follow up incorporating CareLink.
- 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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||REmote MOnitoring Transmission Evaluation of IPGs|
|Study Start Date:||March 2008|
|Study Completion Date:||February 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Other: CareLink Remote Monitoring
Substitution of CareLink Remote Monitoring of Pacemakers for in-clinic pacemaker follow-up visits
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631709
|Canada, British Columbia|
|Kelowna General Hospital|
|Kelowna, British Columbia, Canada|
|Southlake Regional Hospital|
|Newmarket, Ontario, Canada|
|CHUQ, L'Hotel Dieu de Quebec|
|Quebec City, Quebec, Canada|