To observe and evaluate the safety and efficacy of TaurusOne® transcatheter aortic valve system in patients with severe calcific aortic stenosis through a prospective, multicenter clinical trial using objective performance criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
The TaurusOne® Transcatheter Aortic Valve System consists of an aortic valve, an associated delivery catheter and a loading system. The aortic valve consists of a self-expanding nitinol frame, a sealing skirt and valve leaflets, which are made of bovine pericardium. The delivery system is mainly composed of conical head, opacity ring, inner tube, top ring, middle tube, outer tube, booster rod, stress diffusion catheter, handle, etc. The outflow end of the aortic valve is provided with three fixing holes evenly distributed on the circumference on the top ring of the delivery catheter, so as to facilitate the installation, delivery and release of the aortic valve. Before the operation, the aortic valve needs to be installed into the sheath of the delivery catheter as required.
Peiga Medical Technology (Suzhou) Co., Ltd
Suzhou, Jiangsu, China
All-cause mortality at 12 months
All-cause mortality
Time frame: 12 months
Device success rate (Immediate after procedure)
* Successful delivery and release of vascular access and prosthetic aortic valve, and successful withdrawal of the delivery catheter * Accurate placement of prosthetic aortic valve at the anatomical site * Prosthetic aortic valve meets the desired requirements (mean valve gradient \< 20 mm Hg or maximal flow velocity \< 3 m/s; No severe prosthetic valve regurgitation or perivalvular leak)
Time frame: Immediate after procedure
Procedure success rate
A successful procedure is defined as successful implantation of the prosthetic aortic valve at the correct anatomical site 72 hours after the operation or before discharge without severe prosthetic valve regurgitation or perivalvular leak.
Time frame: 72 hours after procedure/prior to discharge
Cardiac function improvement
NYHA functional classification
Time frame: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
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