Safety & Efficacy of the J-Valve Ausper System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation
Safety & Efficacy of the J-Valve Ausper System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation
A prospective, multicenter, nonrandomized, single-arm, clinical study.
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:

 1. Signed Informed Consent

 2. Age ≥18years of age

 3. Presents with symptomatic aortic stenosis and/or aortic regurgitation, as well as NYHA
 rating of NYHA ≥ II

 4. 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)

 5. Has a diagnosis from at least one interventional cardiologist and two cardiac surgeons
 that the patient may benefit from a valve implantation

 6. 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

 7. Without severe pulmonary arterial hypertension

 8. The patient is willing to cooperate with all follow-up visits.

 Anatomical Inclusion Criteria:

 9. Aortic annulus >19mm and <29mm, standardized using cardiac CT measurements;

 10. Ascending aortic diameter <50mm at the sinotubular junction.

 Exclusion Criteria:

 1. Patients with infection or who have any sign of infection

 2. Previous history of endocarditis or patients with active endocarditis

 3. 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)

 4. Any cardiac mass discovered during echocardiography, left ventricular or atrial
 thrombosis

 5. Suffering from uncontrollable atrial fibrillation

 6. Hereditary hypertrophic cardiomyopathy

 7. Mitral or tricuspid valve insufficiency (Class Ⅱ regurgitation or greater)

 8. Has previously undergone aortic valve implantation (mechanical valve or biological
 valve frame)

 9. Is known to be allergic to contrast agents, aspirin, heparin, ticlopidine medications,
 nitinol or porcine products

 10. Is known to be contraindicated for or is allergic to all anti-coagulants or is unable
 to use anti-coagulants during the study

 11. 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.

 12. Has experienced a cerebrovascular accident (CVA) within the last 6 months

 13. Patients suffering from stenosis of the carotid, internal carotid, or vertebral
 arteries (70%)

 14. White cell count <3×109/L, platelet count<50×109/L

 15. Hemoglobin <90 g/L

 16. Severely lowered left ventricular function, left ventricular ejection fraction < 20 %

 17. Aortic aneurysm in the abdomen or chest

 18. Hepatic encephalopathy or acute active hepatitis

 19. Currently undergoing dialysis or baseline creatine levels >2.5 mg/dL (221μmoI/L)

 20. Prone to bleeding, has a history of clotting disorders or refuses blood transfusions

 21. Active ulcer or active gastrointestinal (GI) bleeding

 22. Suffering from nervous system diseases that severely influence the patients' ability
 to move or to perform daily activities

 23. Patients with severe dementia

 24. Any reason for emergent surgery

 25. Taking part in other clinical trials for pharmaceuticals or medical devices

 26. 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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