临床试验/NCT06804148

NCT06804148招募中不适用

MYVAL Transcatheter Heart Valve System - Prospective German Multicenter Registry

Prof. Dr. med. Ingo Eitel1 个研究点分布在 1 个国家目标入组 2,000 人开始时间: 2025年1月1日最近更新: 2025年2月3日

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 2,000
试验地点: 1
主要终点: It is a composite of: - All-cause mortality - All stroke - Moderate or severe paravalvular regurgitation

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Rational of the Myval THV - Prospective German Multicenter Registry is to evaluate the performance of this relatively new but very promising TAVR valve in a consecutive real-word, all-comers registry and to assess the long-term durability and efficacy of the Myval THV.

研究设计

研究类型: Observational
观察模型: Other
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 is going to be treated with Myval THV
•Age ≥ 18 years
•Ability to give informed consent

排除标准

•Pregnant and lactating women
•Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media.
•Patients in whom anti-platelet and/or anticoagulant therapy are contra-indicated.
•Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the registry

结局指标

主要结局

It is a composite of: - All-cause mortality - All stroke - Moderate or severe paravalvular regurgitation

时间窗: 5 Year

次要结局

未报告次要终点

研究者

发起方

Prof. Dr. med. Ingo Eitel

申办方类型

Other

责任方

Sponsor Investigator

主要研究者

Prof. Dr. med. Ingo Eitel

Head of department of medical clinic II

University of Luebeck

研究点 (1)

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