JPRN-jRCT2032220262进行中（未招募）未知
Multicenter, single-arm study to assess the performance of NIHA-001
Shimizu Yu0 个研究点目标入组 215 人开始时间: 2022年8月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 215
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Patients who have consented to participate in the clinical trial in writing
- •(2) Patients aged 20 years or older at the time of consent acquisition
- •(3) Patients who have been diagnosed with heart failure by the time consent is obtained and have been judged by a doctor to be NYHA I, II, III or IV at the time of screening.
- •(4) Patients not having a cardiac pacemaker or an implantable electronic device for pacing such as implantable cardioverter-defibrillators when their consent is obtained, and not planing to have it during the clinical trial.
- •However, patients who have implantable electronic device when their concent is obtained, but it does not work due to dead batteries etc. and who not plan to operate the device during the trial are eligible to enroll.
排除标准
- •(1) Patients after congenital heart disease or heart transplantation
- •(2) Patients suffering from pulmonary hypertension not caused by heart failure at the time of obtaining consent
- •(3) Dextrocardia patients
- •(4) Patients participating in other clinical studies or clinical trials. However, this excludes observational studies that do not involve intervention with pharmaceutical products, etc.
- •(5) Other patients who are judged to be ineligible by the investigator or sub investigator
研究者
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