The TRICURE EU PIVOTAL TRiCares Topaz Transcatheter TRICUspid Heart Valve REplacement System EUropean PIVOTAL Study

TRiCares13 个研究点分布在 2 个国家目标入组 80 人2024年8月29日

适应症Tricuspid Valve Regurgitation Heart Valve Disease Cardiovascular Diseases

干预措施Transcatheter Tricuspid Valve Replacement

概览

阶段: 不适用
干预措施: Transcatheter Tricuspid Valve Replacement
疾病 / 适应症: Tricuspid Valve Regurgitation
发起方: TRiCares
入组人数: 80
试验地点: 13
主要终点: Composite of MAE
状态: 招募中
最后更新: 17天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

详细描述

The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.

注册库

clinicaltrials.gov

开始日期

2024年8月29日

结束日期

2030年12月30日

最后更新

17天前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

TRiCares

责任方

Sponsor

入排标准

入选标准

•Adult patients
•Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
•Institutional Heart Team evaluates patient as being at increased operative risk

排除标准

•Patient in need of emergent intervention
•Patient who is hemodynamically unstable
•Anatomical contraindications for implantation with study device
•Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet

研究组 & 干预措施

Transcatheter Tricuspid Valve Replacement

Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System

干预措施: Transcatheter Tricuspid Valve Replacement

结局指标

主要结局

Composite of MAE

时间窗: 30 day post-intervention

Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications.

Investigational Device Success

时间窗: immediately post-intervention

Device success defined as a reduction in tricuspid regurgitation immediately post-intervention

次要结局

Six minute walk test(30 days, 6 months, annual for five years post-intervention)
Reduction in Tricuspid Regurgitation (TR) Grade(30 days, 6 months, annual for five years post-intervention)
New York Heart Association (NYHA) Function Class(30 days, 6 months, annual for five years post-intervention)