NCT07414342招募中不适用
Safety and Efficacy of the RENATUS® Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis
Beijing Balance Medical Technology Co., Ltd4 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2026年2月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 4
- 主要终点
- Cumulative all-cause mortality (all-cause mortality includes both cardiac and non-cardiac deaths)
研究概览
简要总结
This study is a prospective, non-randomized, observational, post-market follow-up trial designed to evaluate the safety and efficacy of the RENATUS® Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
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
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients deemed eligible for TAVR by the treating physician, including those at high, intermediate, or low surgical risk, with a calculated Society of Thoracic Surgeons (STS) risk score;
- •Symptomatic patients with severe aortic stenosis, defined by echocardiography as having at least one of the following:
- •Mean transvalvular pressure gradient ≥40 mmHg (1 mmHg = 0.133 kPa),
- •Peak aortic jet velocity ≥4.0 m/s,
- •Aortic valve area <1.0 cm², or Indexed effective orifice area <0.6 cm²/m²;
- •Patients who understand the purpose of the trial, voluntarily agree to participate, provide written informed consent, and are willing to undergo required examinations and clinical follow-up.
排除标准
- •Patients with a life expectancy of ≤1 year following prosthetic valve implantation;
- •Patients who have experienced an acute myocardial infarction or undergone any therapeutic cardiac surgery within the past month;
- •Patients with minimal or no calcification of the aortic annulus;
- •Patients with aortic root anatomy or pathology deemed unsuitable for prosthetic valve implantation;
- •Patients with multivalvular disease (severe stenosis and/or regurgitation);
- •Patients with hematologic cachexia, including leukopenia (WBC <3×10⁹/L), acute anemia (Hb <90 g/L), thrombocytopenia (PLT <50×10⁹/L), bleeding diathesis, or coagulopathy;
- •Patients with untreated coronary artery disease requiring revascularization;
- •Patients with obstructive hypertrophic cardiomyopathy;
- •Patients with severe left ventricular dysfunction (LVEF <20%);
- •Patients with severe right ventricular dysfunction;
- •Patients with intracardiac masses, fresh thrombi, or vegetations detected by echocardiography;
- •Patients unable to tolerate anticoagulant or antiplatelet therapy;
- •Patients who have experienced a cerebrovascular accident (CVA)-including ischemic or hemorrhagic stroke-within the past 3 months;
- •Patients with decompensated renal insufficiency;
- •Patients with active infective endocarditis or other active infections;
- •Patients with untreated conduction system disease requiring pacemaker implantation;
- •Patients who have participated in another drug or medical device clinical trial and have not yet reached the primary endpoint assessment timepoint;
- •Any other condition, as determined by the investigator, that renders the patient unsuitable for transcatheter aortic valve intervention.
研究组 & 干预措施
RENATUS® TAVR treatment
Experimental
干预措施: RENATUS® TAVR (Device)
结局指标
主要结局
Cumulative all-cause mortality (all-cause mortality includes both cardiac and non-cardiac deaths)
时间窗: 1 year post-procedure
次要结局
- Procedural success rate(Perioperative)
- Device success rate;(Perioperative)
- All-cause mortality at 1, 3, 5, and 10 years(1, 3, 5, and 10 years)
研究者
研究点 (4)
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