Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve Replacement System With Retrievable Delivery Catheter System

This is an interventional treatment trial for Aortic Stenosis Read More

Inclusion Criteria:

• Patients who are willing to participate and sign the informed consent and can cooperate with the whole trial process;
• Age ≥70 years old;
• Patients with severe calcified aortic stenosis confirmed by echocardiography (trans-aortic valve flow velocity ≥ 4.0m /s, or trans-active valvular pressure difference ≥40mmHg (1mmHg=0.133kPa), or aortic valve orientation area < 0.8cm2, or effective aortic valve orifice the product index is < 0.5cm2/m2);
• Appear obvious symptoms caused by aortic stenosis, NYHA class Ⅱ or higher;
• The cardiac team (at least two specialists in cardiovascular surgery) assessed the patient as unsuitable for routine surgery ;
• The life expectancy of the patient after implantation of the prosthetic valve was evaluated by the cardiac team (at least two specialists in cardiovascular surgery) as more than one year;
• Patients with aortic ring diameter ≥18mm and ≤29mm (cardiac CT measurement);
• The diameter of the ascending aorta of the patient was < 50mm.

Exclusion Criteria:

• Patients with bacteremia or toxemia;
• previous history or active endocarditis;
• Acute myocardial infarction (Q-wave MI, or non-Q-wave MI with increased creatine kinase isoenzyme and/or troponin T) within 30 days;
• Echocardiography found any intracardiac mass, left ventricle or atrial thrombosis, vegetations;
• Symptomatic atrial fibrillation that cannot be improved by medication;
• Familial hypertrophic cardiomyopathy;
• Mitral valve and tricuspid valve insufficiency (reflux Ⅱ level above);
• Prior aortic valve grafts (mechanical or biological valve stents);
• Known allergy to contrast agent, aspirin, heparin, ticlopidine, nickel-titanium memory alloy, or bovine products;
• Known to be contraindication or allergic to all anticoagulant regimens, or unable to use anticoagulant during the test;
• Other serious diseases that may reduce life expectancy to less than 12 months (e.g. clinically recurrent or metastatic cancer, congestive heart failure, etc.)
• Current drug abuse problem (e.g., alcohol, cocaine, heroin, etc.); Plan to undergo surgery that may cause nonadherence to protocol or confusion in data interpretation.
• Cerebrovascular accident (CVA) in the past 6 months;
• Patients with common or internal carotid or vertebral artery stenosis (> 70%);
• WBC count < 3×109/L, platelet count < 50×109/ L;
• Hemoglobin < 90g/L;
• Patients with severe coagulation dysfunction;
• Severe left ventricular dysfunction, left ventricular ejection fraction < 20%;
• Abdominal or thoracic aortic aneurysm;
• Hepatic encephalopathy or acute active hepatitis;
• Receiving dialysis or a baseline creatinine level of > 3.0 mg/dL (266μmol/L);
• Have bleeding tendency or history of coagulation disease or refuse blood transfusion;
• Have active gastric ulcer or active gastrointestinal (GI) bleeding;
• Suffer from neurological diseases that seriously affect the ability to move or live in daily life;
• People with mental illness or mental disorder who cannot express themselves normally;
• Need emergency surgery for any reason;
• Screening participants who had participated in other drug or medical device clinical trials within the previous 3 months;
• Other conditions considered by the investigator to be inappropriate for participation in this clinical trial.