临床试验/ACTRN12616000718448

ACTRN12616000718448暂停未知

A Feasibility Study to Assess Safety and Efficacy of the Transapical and Transfemoral JenaValve Pericardial TAVR (Transcatheter Aortic Valve Replacement) System in the Treatment of Patients with Symptomatic Severe Aortic Regurgitation (AR)

JenaValve Technology, Inc.0 个研究点目标入组 15 人开始时间: 2016年5月30日最近更新: 2020年1月13日

适应症

试验速览

阶段: 未知
状态: 暂停
发起方: JenaValve Technology, Inc.
入组人数: 15

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Non-randomised trial
主要目的: Treatment
盲法: Open (masking not used)

入排标准

年龄范围: 18 Years 至 o limit（—）
性别: All

入选标准

•1. Patient with severe aortic regurgitation (AR) assessed by echocardiography
•2. Patient at high risk for open surgical valve replacement
•3. Patient symptomatic according to NYHA functional class II or higher.

排除标准

•1. Congenital uni- or bicuspid aortic valve morphology
•2. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
•3. Endocarditis or other active infection
•4. Need for urgent or emergent TAVR procedure for any reason
•5. Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device

研究者

发起方

JenaValve Technology, Inc.

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