Clinical Trial in China for Aortic Valve Stenosis

This study is a prospective, multicenter, single-arm, clinical study.

Inclusion criteria

• Age ≥ 65;
• Patients with symptomatic aortic valve regurgitation diseases, and New York Heart Association (NYHA) ≥ II;
• Subject must have Society of Thoracic Surgeons (STS) score ≥8% or have been evaluated as inoperable by the surgical team [defined as rate of death #50% within 30 d post-surgery or accompanied with irreversible occasions of other factors prevent surgeries (such as heavily calcified (porcelain) ascending aorta, weakness, chest malformation, liver dysfunction, pulmonary dysfunction and so on ); (Note: age of inoperable patients can be expanded to ≥ 50);
• Aortic valve anatomy is suitable for TAVR evaluated by the investigators;
• Patients who can sign informed consent form, and are willing to accept relevant examinations and clinical follow-ups.

Exclusion criteria

• Active endocarditis;
• Acute myocardial infarction or coronary revascularization occurred within 1 month before procedure;
• Cerebrovascular accident (CVA) occurred within 30 days before procedure;
• The echocardiogram indicates the presence of mass, thrombus or vegetation in left ventricle and left atrium;
• Hypertrophic obstructive cardiomyopathy;
• Other valve diseases that need interventions;
• Previous aortic valve implantation (mechanical or biological);
• Allergic to Nickel-titanium alloys or contrast agents or cattle-originated products;
• Known allergy or contraindication to all anticoagulation, or anticoagulation can not be used during the TAVR;
• In presence one of the following (from selection to the day of procedure index): a other diseases that may shorten life expectancy to less than 12 months (recurrent or metastatic cancer, congestive heart failure); b drug abuse (such as cocaine, heroin and so on); c planned additional operations that may result in incompliance or data confusion;
• Stenosis of common carotid artery, internal carotid artery or vertebral artery #70%;
• Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%;
• Hepatic encephalopathy or acute active hepatitis;
• Receiving hemodialysis;
• Bleeding tendency or history of coagulopathy or refuse to receive transfusion;
• Active gastrointestinal (GI) ulcer or bleeding;
• Severe dementia;
• Patients who need emergency surgery for any reason;
• Patients are participating in other drugs or medical devices clinical trial;
• Pregnant or plan to be pregnant, or are taking estrogen or estrogen-like drugs (Women suspected of pregnancy must have a negative serum or urine test for human villous gonadotropin prior to enrollment in the study);
• Other inappropriate occasions according to the investigators.