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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
89
Shanghai Zhongshan Hospital
Shanghai, China
All cause mortality or major stroke at 12 months.
Time frame: 12 months
MACCE(major adverse cardiovascular and cerebrovascular events)
MACCE is defined as a composite of: * Myocardial infarction (MI) * Hemorrhage * renal failure * vascular complications * block * ventricular arrhythmias
Time frame: 30 days, 3, 6 and 12 months
Device success
Device success is defined as * The device successfully enter the vascular approach, transport and release * The valve is placed in the correct anatomical position * The valve achieve the expected effect (mean aortic pressure \< 20mmHg or peak velocity \< 3m/s, with no severe aortic regurgitation or paravalvular leakage)
Time frame: 7 days post-operation
Valve performance
Valve performance means: * Transvalvular mean gradient * Effective orifice area * Degree of aortic valve regurgitation (transvalvular and paravalvular)
Time frame: 30 days, 3, 6 and 12 months
The improvement of heart function
Time frame: 30 days, 3, 6 and 12 months
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