Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System (TAVI)

This is an interventional treatment trial for Severe Aortic Stenosis Read More

Inclusion Criteria:

• Subjects ≥ 65 years of age;
• Severe aortic stenosis, as defined by ultrasonic cardiogram (peak velocity ≥4.0 m/s, or mean transaortic systolic pressure gradient ≥40 mmHg, or an aortic valve area of <1.0 cm2) or combined merger; severe aortic insufficiency (regurgitation ≥+++ or regurgitation area ≥0.3cm2) combined with left ventricular dilatation ( LVESD≥50mm or LVEDD≥65mm);or severe aortic valve insufficiency combined with left ventricular systolic dysfunction (LVEF<50%);
• Symptoms suggestive of aortic stenosis, NYHA class III or IV;
• Patients who are considered unsuitable for surgery are considered by two or more than two cardiovascular specialists (≥6% using Society of Thoracic Surgeons scoring system estimation; or there is a severe and irreversible organ damage to the patient, such as lung disease, liver disease, kidney disease and so on; or the patient's physical weakness can not be tolerated by surgery; or have other factors affecting surgery, such as postoperative chest radiosurgery, thoracic deformity, and diffuse severe calcification of the aorta, etc);
• A life expectancy of > 1 year;
• Voluntarily participate in and sign the informed consent form and willing to undergo the related examination and clinical follow-up.

Exclusion Criteria:

• Untreated severe coronary stenosis and needs revascularization; or acute myocardial infarction occurred within 1 months, or coronary stent implantation in 1 month;
• Artificial heart valve and artificial valve ring have been implanted；
• Severe mitral insufficiency (regurgitation ≥+++) or mitral stenosis (valvular area<1.5 cm2)；
• left ventricular or atrial thrombus;
• Aortic annulus diameter <17mm or >27 mm;
• Severe left ventricular dysfunction, ejection fraction <20%；
• Severe pulmonary hypertension or severe right ventricular dysfunction；
• The ascending aortic ≥5cm or Aortic root diameter ≥4.5cm;
• Cerebrovascular event in last 3 months；
• Active endocarditis or other active infection;
• Severe renal failure and requires long-term dialysis treatment；
• Severe liver dysfunction；
• Active peptic ulcer；
• Severe coagulation dysfunction; it is known that all anticoagulant schemes are taboo or allergic, or anticoagulants can not be used in the process of testing；
• Severe respiratory failure；
• Severe Alzheimer's disease；
• Patients who were enrolled in any other study in one month;
• Other cases which the researchers believe that it is not suitable to participate in.