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临床试验/NCT04647864
NCT04647864Unknown不适用

The Coronary AccEss After Tavi Registry - A Multicenter Prospective Registry for the Coronary Access After TAVI

University of Padova1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2021年1月28日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
1
主要终点
Successful selective cannulation of both coronary arteries

研究概览

简要总结

The CAvEAT study is a not for profit, international, multicenter study aimed to assess the feasibility of selective coronary angiography (CA) after Transcatheter Aortic Valve Implantation (TAVI), to investigate predictors of successful selective cannulation (anatomical, technical, etc.) and to investigate if there is a significant difference among different type of transcatheter valves in selective coronary cannulation.

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

入选标准

  • Symptomatic aortic valve disease (stenosis or combined stenosis and regurgitation) candidate to TAVI according to local Heart Team evaluation, including valve-in-valve procedure due to degeneration of a previously implanted surgical bioprosthesis, who undergo coronary access in the same session of TAVI, immediately after transcatheter valve deployment (the procedures have to be consecutive);
  • Provision of signed informed consent;
  • Age ≥18 Years.

排除标准

  • Chronic Kidney Disease stage IV-V (without dialytic treatment; otherwise, patients in dialytic treatment could be included);
  • Current participation in an interventional clinical study;
  • Age < 18 years.

结局指标

主要结局

Successful selective cannulation of both coronary arteries

时间窗: Immediately after TAVI

Successful selective cannulation of both coronary arteries

次要结局

  • Successful selective cannulation of only left coronary artery(Immediately after TAVI)
  • Successful selective cannulation of only right coronary artery(Immediately after TAVI)

研究者

发起方
University of Padova
申办方类型
Other
责任方
Sponsor

研究点 (1)

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