NCT00631709

REmote MOnitoring Transmission Evaluation of IPGs

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Pacemaker

Interventions

Type	Name	Description
OTHER	CareLink Remote Monitoring	Substitution of CareLink Remote Monitoring of Pacemakers for in-clinic pacemaker follow-up visits

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-11-01
• Completion: 2010-02-01
• First posted: 2008-03-10
• Last updated: 2018-04-26

Locations

3 sites across 1 country: Canada