NCT07174531已完成不适用
Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Renato® Transcatheter Valve-in-Valve System
Beijing Balance Medical Technology Co., Ltd1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年5月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- All-cause death
研究概览
简要总结
The Renato® transcatheter valve-in-valve system, developed by Balance Medical, is undergoing a multicenter registry trial across China. The study enrolls patients whose previously implanted surgical or transcatheter bioprosthetic valves have deteriorated and who are at high risk for repeat open-heart surgery. A new bioprosthetic valve is delivered via a transcatheter approach and positioned inside the failing valve, restoring valve function .
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-existing bioprosthetic valve with clinically significant structural deterioration (≥ moderate stenosis or regurgitation) in the mitral, aortic, or tricuspid position, mandating re-intervention.
- •Estimated high surgical risk (STS predicted risk of mortality ≥ 8 %) or formal contraindication to redo surgical as confirmed by an independent multidisciplinary heart-team review.
排除标准
- •Small true internal diameter of the failing bioprosthesis deemed unsuitable for valve-in-valve therapy by the independent heart-team.
- •Failed mitral bioprosthesis with estimated post-procedural left-ventricular outflow tract obstruction (LVOTO) gradient ≥ 30 mmHg or LVOTO risk classified as "high" by the independent heart-team.
- •Failed tricuspid bioprosthesis with concomitant severe pulmonary hypertension (systolic pulmonary artery pressure > 60 mmHg).
- •Any additional native or prosthetic valve lesion requiring concomitant surgical intervention, as determined by the independent heart-team.
- •More than trivial paravalvular leak around the failing bioprosthesis.
- •Intracardiac thrombus, mass, or vegetation documented by imaging.
- •Myocardial infarction, coronary-stent implantation, cardiac rhythm-device implantation, stroke, or transient ischemic attack within 30 days before screening.
- •Significant coronary artery disease mandating revascularization.
- •Active infective endocarditis within 6 months of screening.
- •Active infection requiring systemic antibiotic therapy at the time of screening.
- •Life expectancy < 12 months for any non-cardiac condition.
结局指标
主要结局
All-cause death
时间窗: 12 months.
Cardiac and non-cardiac mortality will be captured for all enrolled patients.
次要结局
- Safety Parameters(12 months)
研究者
研究点 (1)
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