To evaluate the safety and effectiveness of the TaurusTrio™ Heart Valve System in a patient population with symptomatic severe AR requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).
Patients who voluntarily participate and sign the informed consent and are able to comply with the entire trial process;
Age ≥ 18 years;
Jet width ≥ 65% of LVOT
Vena contracta width of > 6 mm
Congenital uni- or bicuspid aortic valve morphology；
Previous prosthetic aortic valve (bioprosthesis or mechanical) implant；
Mitral regurgitation or Tricuspid regurgitation> moderate；
Clinically significant coronary artery disease (CAD) requiring revascularization within 30 days prior to index procedure, or planned CAD revascularization procedure within 12 months after index procedure；
Single group
TaurusTrio™ Heart Valve System
DeviceThe TaurusTrio™ Heart Valve System contains the following sub-components: a prosthetic transcatheter porcine pericardial aortic valve, 20Fr Introducer Sheath System, transfemoral Delivery Catheter, and Loading Tool.
All-cause mortality at 12 months
All-cause mortality
Improvement in quality of life (QoL) at 12 months over baseline, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Improvement in quality of life (QoL)
Composite safety endpoint at 30 days
all-cause death；all stroke； life-threatening or major bleeding；acute kidney injury (AKI) stage 2, 3 or dialysis；major vascular complications；surgery/intervention related to the device (including coronary intervention)；permanent pacemaker implantation；moderate or severe total aortic regurgitation
Technical Success at exit from OR, hybrid room or cath lab post-index procedure
Absence of procedural mortality; and Successful access, delivery, and retrieval of transcatheter delivery system; and Deployment and correct positioning of a single intended THV; and Freedom from re-intervention related to the device or access procedure
Device Success at 1-month consisting of
Absence of procedure mortality; and Correct position of a single prosthetic heart valve Intended performance of the prosthetic heart valve (i.e., no prosthesis mismatch and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s; and no moderate or severe prosthetic valve regurgitation) Intended performance of the prosthetic heart valve (i.e., no prosthesis mismatch and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s; and no moderate or severe prosthetic valve regurgitation)
Procedural Success at 1-month consisting of
Device success at 30 days; and No device- or procedure-related serious adverse events (defined as below): i) No disabling or non-disabling stroke ii) No life-threatening bleeding (\>4 units PRBC) iii) No acute kidney injury - Stage 2 or 3 (including dialysis) iv) No major vascular complication v) No myocardial infarction or cardiac ischemia requiring PCI or CABG vi) No valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)
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