NCT06818435招募中不适用
Portuguese Registry With Meril Myval THV Series - MyPORTuVal Registry
Portuguese Association of Interventional Cardiology6 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年5月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Safety of Myval valve and TAVI procedure
研究概览
简要总结
A prospective, single-arm, multi-centre registry to evaluate the safety and performance of Myval THV series using Transcatheter Aortic Valve Implantation (TAVI) procedure in patients with symptomatic severe native aortic valve stenosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over the age of 18 years with symptomatic aortic stenosis (severe AS), intended to perform TAVI procedure using Myval THV series as assessed by Heart Team.
- •Patient has provided written informed consent as approved by the Ethics Committee (EC)
- •Patient is willing to undergo all registry procedures and follow-up requirements
排除标准
- •Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media.
- •Ongoing infective endocarditis or any similar infection.
- •Pregnant or lactating females.
- •Liver failure (Child-Pugh Class B or C)
- •Patient is currently participating in another clinical investigation where the primary endpoint has not been achieved.
- •Any condition, which in the investigator opinion, would preclude safe participation of the patient in the Registry.
结局指标
主要结局
Safety of Myval valve and TAVI procedure
时间窗: 30 days
Composite of: * All-cause mortality * All stroke * Acute kidney injury (stage 2, 3 and 4) * Bleeding (Type 3 and 4) * Moderate or severe paravalvular leak * Major vascular complications * Conduction disturbances resulting in new permanent pacemaker implantation
次要结局
- Safety and Performance of Myval valve and TAVI procedure(30 days and 12 Months)
研究者
研究点 (6)
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