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临床试验/NCT07761273
NCT07761273Enrolling By Invitation不适用

Tricuspid Valve Reconstruction Using the Right Atrial Appendage

Zagazig University3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年4月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
30
试验地点
3
主要终点
Mortality

研究概览

简要总结

we use part of the cardiac chambre for replacement of destroyed valve on right side of the heart

详细描述

Tricuspid Valve Reconstruction Using the Right Atrial Appendage by harvesting appropriate size then reconstruction as bileaflet valve after reinforcement of the annulus by pericardial band then the neovalve fixed to papillary muscles of the right ventricle by artificial chorda anchored by teflon pledgets

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patient need tricuspid valve replacement

排除标准

  • patient refusal

研究组 & 干预措施

right atrial appendage

Experimental

right atrial appendage used for tricuspid valve reconstruction

干预措施: Tricuspid Valve Reconstruction (Procedure)

tissue valve

Active Comparator

tissue valve used for tricuspid valve replacement

干预措施: tricuspid valve replacement (Procedure)

结局指标

主要结局

Mortality

时间窗: 30 day post operative

perioperative and short-term mortality, with no major procedure-related surgical complication

Morbidity

时间窗: 30 day post operative

measuring pressure gradient

时间窗: 6 months postoperative

Follow-up echocardiography by measuring pressure gradient across the neo valve

Thromboembolic Risk checklist

时间窗: 6 months postoperative

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Amr Elsayed Tawfek Ibrahim

assistant prof

Zagazig University

研究点 (3)

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