Safety & Efficacy of the J-Valve Ausper System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation

To evaluate the safety and efficacy of the J-Valve Ausper system for the treatment of patients with severe aortic stenosis and/or aortic regurgitation with elevated risk for surgery.

Inclusion criteria

• Signed Informed Consent
• Age ≥18years of age
• Presents with symptomatic aortic stenosis and/or aortic regurgitation, as well as NYHA rating of NYHA ≥ II
• Has undergone the diagnosis of at least one interventional cardiologist and two cardiac surgeons: the patients are contraindicated for traditional open heart valve replacement surgery (defined as 30 days post-op mortality risk >50%, irreversible complications, or other influential post-operative factors [such as severe calcification in the ascending aorta and aortic valve, weak physical condition, chest deformities, severe liver diseases, severe lung diseases, etc.] or high risk for surgery (LogEuroSCORE≥20% and or STS≥8)
• Has a diagnosis from at least one interventional cardiologist and two cardiac surgeons that the patient may benefit from a valve implantation
• Severe aortic stenosis with electrocardiography results as follows: mean transvalvular pressure gradient ≥40 mmHg or maximal forward aortic blood flow velocity of ≥4.0 m/s, aortic valve area < 0.8 cm2 (or AVA index < 0.5 cm2/m2); and/or severe aortic regurgitation, electrocardiography results show symptomatic moderate regurgitation or severe regurgitation
• Without severe pulmonary arterial hypertension
• The patient is willing to cooperate with all follow-up visits.

Anatomical Inclusion Criteria:

• Aortic annulus >19mm and <29mm, standardized using cardiac CT measurements;
• Ascending aortic diameter <50mm at the sinotubular junction.

Exclusion criteria

• Patients with infection or who have any sign of infection
• Previous history of endocarditis or patients with active endocarditis
• Incidence of acute myocardial infarction within the past 30 days (Q-wave MI, or non Q-wave MI with creatine kinase, an increase in troponin T)
• Any cardiac mass discovered during echocardiography, left ventricular or atrial thrombosis
• Suffering from uncontrollable atrial fibrillation
• Hereditary hypertrophic cardiomyopathy
• Mitral or tricuspid valve insufficiency (Class Ⅱ regurgitation or greater)
• Has previously undergone aortic valve implantation (mechanical valve or biological valve frame)
• Is known to be allergic to contrast agents, aspirin, heparin, ticlopidine medications, nitinol or porcine products
• Is known to be contraindicated for or is allergic to all anti-coagulants or is unable to use anti-coagulants during the study
• Is known to have one of the following conditions (according to evaluations beginning from screening through the day of the procedure):

• Other diseases that may reduce the life expectancy to less than 12 months (such as clinically recurrent or metastatic cancer, congestive heart failure, etc.)
• Currently has drug abuse problems (such as alcohol, cocaine, heroin, etc.)
• Plans to undergo surgery that may result in non-compliance with the study protocol or that may cause confusion in data interpretation.
• Has experienced a cerebrovascular accident (CVA) within the last 6 months
• Patients suffering from stenosis of the carotid, internal carotid, or vertebral arteries (70%)
• White cell count <3×109/L, platelet count<50×109/L
• Hemoglobin <90 g/L
• Severely lowered left ventricular function, left ventricular ejection fraction < 20 %
• Aortic aneurysm in the abdomen or chest
• Hepatic encephalopathy or acute active hepatitis
• Currently undergoing dialysis or baseline creatine levels >2.5 mg/dL (221μmoI/L)
• Prone to bleeding, has a history of clotting disorders or refuses blood transfusions
• Active ulcer or active gastrointestinal (GI) bleeding
• Suffering from nervous system diseases that severely influence the patients' ability to move or to perform daily activities
• Patients with severe dementia
• Any reason for emergent surgery
• Taking part in other clinical trials for pharmaceuticals or medical devices
• Those who are pregnant, plan to become pregnant, or who are taking estrogen or estrogen-like drugs (women suspected of being pregnant must test negative on a urine pregnancy test or for chorionic gonadotropin serum).

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