跳至主要内容
临床试验/NCT00631709
NCT00631709已完成4 期

REmote MOnitoring Transmission Evaluation of IPGs

Medtronic Cardiac Rhythm and Heart Failure3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2008年3月1日最近更新:
适应症
干预措施

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:

  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.

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

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

Experimental

Pacemaker Patients

干预措施: CareLink Remote Monitoring (Other)

研究者

发起方
Medtronic Cardiac Rhythm and Heart Failure
申办方类型
Industry
责任方
Sponsor

研究点 (3)

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