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临床试验/NCT03474315
NCT03474315Unknown不适用

Interactive Patient's Assistant to Optimize Long-term Care in Patients With Chronic Health Failure and Determine Which Parameters of CIED Indicate the Requirement for Ambulatory Follow-up

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2018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
600
试验地点
1
主要终点
Ambulatory visit qualified as meaningful due to change in pharmacotherapy or ICD parameters related to tachycardia detection or treatment.

研究概览

简要总结

Patients with chronic heart failure (CHF) and reduced left ventricle ejection fraction benefit from cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD). Currently used devices, besides delivering low and high-energy therapies, record patient's activity and many hemodynamic parameters. However, increasing numbers of patient with CRT and ICD devices produce overload of cardiology centers where patients are admitted to ambulatory visits. Contrarily, there are technological possibilities for remote monitoring proven to be effective in recognizing damage of the implanted device and risk of exacerbation of chronic heart failure. Patients' registries show that majority of ambulatory visits are unproductive and do not result in significant modification of device's parameters. Promising experiences with application of data mining and machine learning techniques allow us to assume probable benefits from using modern methods of data analysis in determination of requirement for ambulatory follow-up on basis of data gathered through telemonitoring and clinical assessment of a patient.

Aim of the study is to find multivariate model predicting the requirement for ambulatory follow-up of IECD.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-90 years old
  • Chronic heart failure (NYHA class I to III)
  • Implanted ICD or CRT (at least 30 days before inclusion)

排除标准

  • 未提供

结局指标

主要结局

Ambulatory visit qualified as meaningful due to change in pharmacotherapy or ICD parameters related to tachycardia detection or treatment.

时间窗: 1 day

Primary outcome is composed of: * any change in pharmacotherapy (modification of agents or doses) related to patient's clinical status assessed during the visit, * any change in tachyarrythmia counter or discriminator status, * any change in tachyarrythmia threshold, * ventricular undersensing or oversensing.

次要结局

  • Ambulatory visit qualified as meaningful due to alarming condition related to ICD.(1 day)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcin Grabowski

Clinical Professor

Medical University of Warsaw

研究点 (1)

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