REmote MOnitoring Transmission Evaluation of IPGs
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 3
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients participating in another study that would affect the objectives of this study
- •Patients who have already previously used a Medtronic CareLink Monitor.
研究组 & 干预措施
1
Pacemaker Patients
干预措施: CareLink Remote Monitoring (Other)
