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临床试验/NCT01626404
NCT01626404已完成不适用

Screening for Advanced Heart Failure Treatment (SEE-HF)

Abbott Medical Devices7 个研究点 分布在 6 个国家目标入组 99 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
99
试验地点
7
主要终点
Proportion of patients

研究概览

简要总结

Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients are underserved. The purpose of this prospective, observational study is to obtain multi-center data on the proportion of patients with CRT and/or ICD who are candidates for advanced heart failure treatment and obtain insights into patient and physician decisions regarding referral for advanced heart failure therapy.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CRT and or ICD device in place.
  • NYHA class III - IV heart failure
  • EF </= 40%
  • Patient is an out-patient
  • Patient is on optimal medical management as tolerated and as defined by primary care physician.
  • Patient has signed an informed consent for data collection.

排除标准

  • Age <18 years or >80 years
  • CRT device that has been implanted < 3 months prior to enrollment
  • Coronary revascularization within 3 months prior to enrollment
  • Patient only has ICD but has CRT planned
  • Non-cardiac disease resulting in life expectancy < 2 yrs
  • Patient is hospitalized or will be hospitalized at this time
  • Known diagnosis of dementia
  • Patient is currently on dialysis
  • Oxygen dependent lung disease
  • Previously or currently treated with LVAD or heart transplantation

结局指标

主要结局

Proportion of patients

时间窗: 12 months

Proportion of heart failure patients followed in outpatient clinic that are NYHA III-IV with LVEF \</= 40% and a CRT and/or ICD who have an indication without contraindication for heart transplantationi and/or DT LVAD.

次要结局

  • Patient's reasons(12 months)
  • Actual and predicted 12 month survival(12 months)
  • Reasons for non-referral(12 months)
  • Simple clinical parameters for referral(12 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (7)

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