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临床试验/NCT06493994
NCT06493994招募中不适用

Myval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry

University of Luebeck1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Time until first occurrence
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

Study goal is to determine the feasibility, procedural success, safety and potential benefit of the Myval transcatheter heart valve (THV) in patients undergone transaxillary (TAX) transcatheter aortic valve replacement (TAVR).

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 has been treatet transaxillary (TAX) with Myval transcatheter aortic valve replacement
  • •BMI <35 kg/m2
  • •Ability to give informed consent

排除标准

  • •History of coronary artery bypass graft and a patent left internal mammary artery (LIMA)
  • •Age ≤18 years
  • •Patients presenting with pregnancy
  • •Patients without informed consent
  • •Expected life expectancy <2 years

结局指标

主要结局

Time until first occurrence

时间窗: 30 Days

* Stroke including ischemic or hemorrhagic stroke, * Systemic embolism, * Major bleeding (BARC type 3-5), or Cardiovascular or unexplained death

次要结局

未报告次要终点

研究者

发起方
University of Luebeck
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. med. Ingo Eitel

Head of the MKII

University of Luebeck

研究点 (1)

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