临床试验/NCT07244939

NCT07244939进行中（未招募）不适用

Cephea South America Feasibility Study

Abbott Medical Devices6 个研究点分布在 2 个国家目标入组 20 人开始时间: 2025年6月17日最近更新: 2026年9月11日

适应症

干预措施

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Abbott Medical Devices
入组人数: 20
试验地点: 6
主要终点: Freedom from all-cause mortality

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

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

入选标准

•Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) per American Society of Echocardiography criteria
•LVEF ≥ 30%
•In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery

排除标准

•Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function
•Need for emergent or urgent surgery

研究组 & 干预措施

Cephea TMVR

Experimental

Treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System

干预措施: Cephea Mitral Valve System (Device)

结局指标

主要结局

Freedom from all-cause mortality

时间窗: 30 days post implant

Primary Safety Endpoint

Reduction of MR to ≤ Grade I

时间窗: 30 days post implant

Primary Effectiveness Endpoint

次要结局

未报告次要终点

研究者

发起方

Abbott Medical Devices

申办方类型

Industry

责任方

Sponsor

研究点 (6)

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