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
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
- 否
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
Marcin Grabowski
Clinical Professor
Medical University of Warsaw
