Pacemaker Clinical Trial
Official title:
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.
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