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Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI

Aortic Valve Stenosis Clinical Trial

Official title:
Clinical Evaluation of the Safety and Performance of the MicroPort's Transcatheter Aortic Valve and Delivery System for Treatment of Severe Aortic Stenosis

Clinical Trial Summary

The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for Surgical Valve Replacement.

Clinical Trial Description

1. Evaluate the performance, safety and clinical benefit of MicroPort's aortic valve prosthesis and delivery system in intervention by peripheral artery.

2. The study Continuous observe 12 months of safety and efficacy. Approximately 89 patients are recruited in the study with native aortic valve stenosis which are considered unsuitable for Surgical Valve Replacement. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02221921
Study type Interventional
Source Shanghai MicroPort Medical (Group) Co., Ltd.
Contact David Liu, Medical Doctor
Phone +86 13911002920
Email davidliu@coremed.com.cn
Status Not yet recruiting
Phase N/A
Start date September 2014
Completion date September 2021
View Details
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