临床试验/NCT01497418

NCT01497418已完成不适用

Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the SJM Transfemoral Delivery System

Abbott Medical Devices2 个研究点分布在 1 个国家目标入组 2 人开始时间: 2011年12月最近更新: 2019年2月4日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Abbott Medical Devices
入组人数: 2
试验地点: 2
主要终点: The objective of this study is to retrospectively and prospectively collect and evaluate the long term safety of the 23mm Portico Transcatheter Aortic Heart

研究概览研究设计入排标准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

Collect and evaluate the long term safety data.

详细描述

The purpose of this study is to collect and evaluate the long term safety data of the 23mm Portico™ Transcatheter Heart Valve and the transfemoral Delivery System previously implanted in subjects with aortic valve disease.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Other

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

•Subject has given written study Informed Consent for participation prior to any study procedures.
•Subject is ≥ 18 years of age or legal age in host country at time of consent.
•Subject currently has a 23mm SJM Portico Transfemoral Transcatheter Heart Valve

排除标准

•Subject currently participating in another investigational device or drug study.
•Subject is unable or unwilling to return for the required follow-up visits.

结局指标

主要结局

The objective of this study is to retrospectively and prospectively collect and evaluate the long term safety of the 23mm Portico Transcatheter Aortic Heart

时间窗: 1 year

Data will be collected at 3 months, 6 months, and 12 months post-implant.

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 (2)

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