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