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

Exclusion Criteria30

• 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；
• 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 <66.0 mm 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 ； (defined as maximal luminal diameter of 50 mm or greater) or atheroma (including if thick \[>5 mm\], protruding or ulcerated)
• Need for urgent or emergent TAVR procedure for any reason；
• Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular 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 artery stenosis (>70%)；
• Patients with severe coagulopathy；
• Severe renal insufficiency (GFR < 30 ml/min) at Screening, OR renal disease requiring renal 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 index procedure；
• Known allergies to to heparin, aspirin, ticlopidine, Clopidogrel, Nitroglycerin and other drugs，contrast agents, nitinol shape memory alloy, tantalum or porcine products；
• Contraindication to intraoperative transesophageal echocardiography and/or Multi-Detector CT (MDCT) scan；
• Estimated life-expectancy of < 24 months；
• Patient is enrolled in another investigational medical device or drug study which has not completed the required primary endpoint follow-up. (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this study);
• Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the patient from providing appropriate informed consent;
• Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments);
• Unable to comply with follow-up requirements;