Safety and Effectiveness of TaurusTrio™ Heart Valve System in Patients With Severe Aortic Regurgitation (AR)

Inclusion Criteria:

• Patients who voluntarily participate and sign the informed consent and are able tocomply with the entire trial process;
• Age ≥ 18 years;
• Adult subjects with severe AR (Grade ≥ 3) as assessed by echocardiography based on ASE (American Society of Echocardiography) using multiparametric approach with:
• Jet width ≥ 65% of LVOT
• Vena contracta width of > 6 mm
• Holodiastolic flow reversal in proximal abdominal/descending aorta
• Jet deceleration rate/Pressure half time <200ms
• AND, For Grade 3:
• Regurgitant volume ≥ 45-59 ml/beat
• Regurgitant fraction ≥ 40-49%
• EROA ≥ 0.2-0.29 cm2
• OR, For Grade 4:
• Regurgitant volume ≥ 60 ml/beat
• Regurgitant fraction≥50%
• EROA ≥ 0.3 cm2 Note: In cases where not all criteria listed for severe AR aremet, the Core Lab will determine severity. Supplemental CMR imaging may be usedto substantiate the degree of AR reported by Core Lab on baseline echo whenimaging is suboptimal, Doppler parameters are discordant or inconclusiveregarding the severity of AR, or when a discrepancy is present between the echofindings and the clinical setting.
• Patients who have symptoms obviously caused by Aortic Regurgitation, such as dyspnea,chest pain, NYHA Class II or higher;
• Patients who are unsuitable for conventional surgery but needs TAVR（It is recommendedto refer to the 2020 ACC/AHA Heart Valve Disease Management Guidelines when evaluatingthe risks of surgical valve surgery），evaluated by the cardiac team (including at leastone interventional cardiologist and one cardiovascular surgeon)
• Patient has suitable anatomy to accommodate the insertion and delivery of theJenaValve Trilogy™ Heart Valve System，evaluated by core laboratory;

Exclusion Criteria:

• 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 revascularizationwithin 30 days prior to index procedure, or planned CAD revascularization procedurewithin 12 months after index procedure；
• Echocardiographic evidence of left ventricular thrombus；
• Endocarditis within 180 days prior to index procedure；
• Hypertrophic cardiomyopathy with or without obstruction；
• Severe pulmonary hypertension (systolic PA pressure >80 mmHg)；
• Severe RV dysfunction as assessed clinically and by echo；
• Severely reduced left ventricular ejection fraction (LVEF <25%)；
• Aortic annular perimeter derived diameter of <21.0 mm or > 28.6 mm or perimeter <66.0mm or >90 mm (assessed by Multi-Detector CT measurement)；
• Aortic annulus angulation > 70° (assessed by Multi-Detector CT measurement)；
• Straight length of ascending aorta of < 55 mm；
• Significant disease of ascending aorta, including ascending aortic aneurysm ； (definedas maximal luminal diameter of 50 mm or greater) or atheroma (including if thick [>5mm], protruding or ulcerated)
• Need for urgent or emergent TAVR procedure for any reason；
• Cardiogenic shock or hemodynamic instability requiring inotropic support orventricular assist device within 30 days prior to index procedure；
• Myocardial infarction < 30 days prior to index procedure；
• Cerebrovascular event (TIA, stroke) < 180 days prior to index procedure；
• Patients with common carotid artery or internal carotid artery or vertebral arterystenosis (>70%)；
• Patients with severe coagulopathy；
• Severe renal insufficiency (GFR < 30 ml/min) at Screening, OR renal disease requiringrenal replacement therapy within 180 days prior to index procedure；
• Blood dyscrasias as defined: leukopenia (WBC < 3000/mm³), or thrombocytopenia (platelets < 90,000/µl) or anemia (Men: Hgb < 8.1 g/dl; Women: Hgb < 7.4 g/dl)；
• Active peptic ulcer or upper gastrointestinal bleeding < 90 days prior to indexprocedure；
• Known allergies to to heparin, aspirin, ticlopidine, Clopidogrel, Nitroglycerin andother drugs，contrast agents, nitinol shape memory alloy, tantalum or porcine products；
• Contraindication to intraoperative transesophageal echocardiography and/orMulti-Detector CT (MDCT) scan；
• Estimated life-expectancy of < 24 months；
• Patient is enrolled in another investigational medical device or drug study which hasnot completed the required primary endpoint follow-up. (Note: Patients involved in along-term surveillance phase of another study are eligible for enrollment in thisstudy);
• Other medical, social, or psychological conditions that in the opinion of anInvestigator precludes the patient from providing appropriate informed consent;
• Severe dementia (resulting in either inability to provide informed consent for thetrial/procedure, prevents independent lifestyle outside of a chronic care facility, orwill fundamentally complicate rehabilitation from the procedure or compliance withfollow-up assessments);
• Unable to comply with follow-up requirements;