NL-OMON45748已完成不适用
CardioMEMS European Monitoring Study for Heart Failure - MEMS HF
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Indicated to receive a CardioMEMS sensor implant per the CardioMEMS* HF System User*s Manual
- •o > 18 years of age
- •o Diagnosis of NYHA Class III Heart Failure at the time of sensor implantation
- •o Hospitalization for worsening HF within 12 months prior to the CardioMEMS HF System implant. For the purposes of this study, a HF hospitalization is defined as an overnight stay in the hospital with signs and symptoms of congestion requiring intensification of treatment for HF
- •o Subjects with reduced Left Ventricular Ejection Fraction (LVEF) must be on stable Guideline Directed Medical Therapy (GDMT) as tolerated
- •o Written informed consent obtained from subject
排除标准
- •* Known coagulation disorders or inability to take two types of blood thinning medications for one month after the sensor is implanted
- •* Subjects deemed a candidate for transplant, Ventricular Assist Device, or hospice care in the next 12 months or are otherwise not expected to be able to complete the study follow up
研究者
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