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临床试验/NCT01548755
NCT01548755Unknown不适用

Workload Assessment of a Home Monitoring Based Follow up for Biotronik ICD and CRTD Patients.

ron sela1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1

研究概览

简要总结

The purpose of this study is to study workload assessment of home monitoring based follow up for ICD or CRTD implanted patient.

详细描述

EP unit device clinic is a very busy clinic. Every 6 month the patients arrive for device follow up where the device parameters, patient condition and arrhythmic events are being reviewed, and reprogramming of the device (if needed) is done. Average net time of patient's stay in the clinic is between 30-45 minutes.

Patients implanted with the Lumax device family allows for a better automated follow up procedure via remote management (Home Monitoring).

The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Approved indication for ICD or CRTD.
  • Implanted with or replaced with a Biotronik Lumax device.
  • Patient is willing and able to sign consent form.
  • Willing and able to attend clinic visits and follow up schedule.
  • Transmission of more than 80% at 3-month FU.
  • Patient older than 18 years.

排除标准

  • No indication for ICD or CRTD implant.
  • Life expectancy shorter than 12 months.
  • Pregnancy.
  • Participation in other clinical studies

研究者

发起方
ron sela
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

ron sela

Ron Sela, MD

Western Galilee Hospital-Nahariya

研究点 (1)

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