TVMR With the Innovalve System Trial - First In Human Israel

Edwards Lifesciences1 个研究点分布在 1 个国家目标入组 1 人2021年10月1日

适应症Mitral Valve Regurgitation (Degenerative or Functional)

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Mitral Valve Regurgitation (Degenerative or Functional)
发起方: Edwards Lifesciences
入组人数: 1
试验地点: 1
主要终点: Absence of implant or delivery related serious adverse events at 30 days
状态: 已完成
最后更新: 去年

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

详细描述

The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the Innovalve mitral valve replacement system

注册库

clinicaltrials.gov

开始日期

2021年10月1日

结束日期

2025年4月1日

最后更新

去年

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Edwards Lifesciences

责任方

Sponsor

入排标准

入选标准

•Clinically significant, symptomatic mitral regurgitation
•High risk for open-heart surgery
•Meets anatomical criteria

排除标准

•Unsuitable anatomy
•Patient is inoperable

结局指标

主要结局

Absence of implant or delivery related serious adverse events at 30 days

时间窗: 30 days

Absence of implant or delivery related serious adverse events

次要结局

Quality of life improvement (KCCQ-12) Kensas City Cardiomyopathy Questionnaire(30 days, 6, 12 months and annually up to 5 years)
NYHA functional class(30 days, 6, 12 months and annually up to 5 years)
Six-minute walk test(30 days, 6, 12 months and annually up to 5 years)
Technical success(Procedure)
Procedural success(30 days)
Reduction in Mitral Regurgitation grade(30 days, 6, 12 months and annually up to 5 years)