REmote MOnitoring Transmission Evaluation of IPGs (REMOTE-IPG)
|ClinicalTrials.gov Identifier: NCT00631709|
Recruitment Status : Completed
First Posted : March 10, 2008
Last Update Posted : April 8, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Pacemaker||Other: CareLink Remote Monitoring||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||REmote MOnitoring Transmission Evaluation of IPGs|
|Study Start Date :||March 2008|
|Primary Completion Date :||November 2009|
|Study Completion Date :||February 2010|
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 (NCT number): 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|