NCT04781660Unknown不适用
A Clinical Research for Safety and Feasibility of Implantable Alginate Hydrogel as a Method of Left Ventricular Restoration in Patients With Heart Failure
Xijing Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Rate of Serious Adverse Device Events
研究概览
简要总结
The objective of this clinical research is to evaluate the safety and effectiveness of Implantable Alginate Hydrogel to reconstruct the left ventricle in the treatment of heart failure
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients must have been able and willing to give written informed consent
- •The patients should be adult (age≥ 18 years and <75 years) males or females
- •The patients must have been on stable, evidence-based therapy for HF
- •The Patients have a LVEF ≤35%
- •NYHA is classified as grade III or IV
- •If female, the patients must have been (a) post-menopausal, (b) surgically sterile, or (c) using adequate birth control and have a negative serum pregnancy test within 7 days prior to administration of the study device.
排除标准
- •Have undergone any therapeutic traumatic heart surgery within 30 days.
- •Hemodynamic instability or cardiogenic shock.
- •Right-sided HF.
- •Patients who presented with a restrictive cardiomyopathy such as due to amyloidosis, sarcoidosis, or hemochromatosis.
- •History of Constrictive pericarditis.
- •History of stroke (within 60 days prior to the surgical procedure).
- •History of myocardial infarction (within 30 days prior to the surgical procedure).
- •An LV wall thickness of the LV free-wall, at the mid-ventricular level, of < 6 mm.
- •Serum creatinine > 2.0 mg/dL, or calculate creatinine clearance rate <25 mL/min
- •Clinically significant liver enzyme abnormalities, i.e., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 2 times the upper limit of normal and/or bilirubin more than 50% above the upper limit of normal.
- •Had been receiving concurrently an investigational product in another clinical trial or had received an investigational product in another clinical trial in the 30 days prior to enrollment.
- •A life expectancy of < 1 year due to comorbidities .
- •Unfit for the minimal invasive treatment.
结局指标
主要结局
Rate of Serious Adverse Device Events
时间窗: 30 days after implantation
Definition of SADE: Any complications related to the device include but not limited: death, stroke, permanent damage to the heart, any situation that requires further intervention, etc.
次要结局
- Incidence of SAE(Within 6 months after implantation)
- NHYA Class level changes rate between baseline and 6 months' follow-up(6 months after implantation)
- Quality of life changes rate between baseline and 6 months' follow-up(6 months after implantation)
- Size of LV changes rate between baseline and 6 months' follow-up(6 months after implantation)
- Device successfully Setup rate(immediately after the implantation)
- Rate of Rehospitalization due to heart failure(within 6 months after implantation)
- LVEF changes rate between baseline and 6 months' follow-up(6 months after implantation)
研究者
研究点 (1)
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