Aortic Regurgitation Clinical Trial
Official title:
A Prospective, Multicenter, Single-armed Trial That Aims to Evaluate the Safety and Efficacy of Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System
The purpose of this study is to demonstrate that transcatheter artificial aortic valve and transcatheter artificial heart values delivery system is associated with a reduction of all-cause mortality in severe aortic stenosis or insufficiency patients who are high risk or ineligible for aortic valve replacement.
Aortic valve diseases is usually caused by rheumatic fever, congenital aortic valve
structural abnormality or degenerative aortic valve calcification. Transcatheter aortic valve
implantation (TAVI) has evolved as an alternative to surgical aortic valve replacement (SAVR)
with now more than 50,000 implantations in patients with symptomatic severe aortic stenosis,
who were considered to be at very high or prohibitive operative risk.
This project take the incidence of all-cause mortality at 12 months since TAVI as the primary
endpoint to evaluate the safety and efficacy, then take the procedure success rate, device
success rate, incidence of severe adverse events, device operative performance, prosthetic
valve performance and quality of life to evaluate transcatheter artificial aortic valve and
transcatheter artificial heart values delivery system of Ningbo Jenscare Biotechnology Co.,
Ltd. in clinical application.
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|---|---|---|---|
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