PrizValve® Transcatheter Aortic Valve Replacement Study
PrizValve® Transcatheter Aortic Valve Replacement Study
The purpose of this clinical study is to evaluate the effectiveness and safety of the
 transcatheter aortic valve system in the treatment of patients with severe aortic stenosis
 who are at high risk of surgery or who are not suitable for surgery.
This study is an multicenter, single-arm, prospective, safety and performance clinical study.
Inclusion Criteria:

 1. Age ≥ 70 years ;

 2. Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography:
 transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve
 blood flow rate ≥4m/s, or aortic Valve area<1.0cm2, or AVA <0.5cm2 /m2);

 3. NYHA ≥ II;

 4. Life expectancy> 12 months;

 5. Patients who are anatomically suitable for transcatheter aortic valve implantation;

 6. After evaluation by two or more cardiovascular surgeons, patients who are unsuitable
 for surgery; or patients who refuse surgery after sufficient communication by the
 surgeons and are at high risk of routine surgery;

 7. Patients who can understand the purpose of the trial, voluntarily participate in and
 signed informed consent form, and are willing to accept relevant examinations and
 clinical follow-ups.

 Exclusion Criteria:

 1. Acute myocardial infarction occurred within 1 month before this treatment;

 2. Congenital single leaf aortic valve;

 3. Any therapeutic cardiac operation (including placement of coronary drug-eluting
 stents) within 30 days;

 4. The patient's heart has been implanted with other artificial heart valves, artificial
 rings, or severe mitral regurgitation (>3+);

 5. Blood system diseases or abnormalities, including leukopenia (WBC<3×109/L), acute
 anemia (HB <90g/L), thrombocytopenia (PLT<50×109/L), bleeding constitution and
 coagulopathy ；

 6. Untreated severe coronary artery stenosis that requires revascularization;

 7. Patients with hemodynamic or respiratory instability, requiring continuous mechanical
 heart assistance or mechanical ventilation;

 8. Patients who need emergency surgery for any reason;

 9. Hypertrophic cardiomyopathy with obstruction;

 10. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%;

 11. The echocardiogram indicates the presence of a heart mass, thrombus or vegetation;

 12. A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;

 13. Are allergic to cobalt-chromium alloys or contrast agents, and cannot tolerate
 anticoagulation and antiplatelet therapy;

 14. The diameter of the aortic valve annulus <16mm or >28mm;

 15. In any case, patients who refuse surgical treatment in emergency situations;

 16. Cerebrovascular accident occurred within 3 months, not including transient ischemic
 attack;

 17. Renal insufficiency is decompensated (creatinine>177umol/L), and/or end-stage renal
 disease requires long-term dialysis;

 18. Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm,
 obvious curvature of the aortic arch, atherosclerosis of the aortic arch, narrowing of
 the abdominal or thoracic aorta, and obvious curvature or extension of the thoracic
 aorta;

 19. The iliac-femoral artery is severely obstructed with calcification, severely tortuous
 or unable to place the 1418F catheter sheath kit;

 20. Active infective endocarditis or other active infections;

 21. Aortic valve leaflets calcified plaque close to the coronary ostium;

 22. Severe disability Alzheimer's disease and unable to take care of oneself in life;

 23. Those who have participated in clinical trials of other drugs or medical devices
 before entering the group and have not yet reached the time limit of the primary
 research endpoint;

 24. The researcher judged that the patient had poor compliance and could not complete the
 study as required.