This study will evaluate the safety and efficacy of postmarket bioprosthetic aortic valve in patients with severe aortic regurgitation undergoing transapical transcatheter aortic valve replacement based on 3D simulation technology using a prospective, randomized controlled study.

Inclusion Criteria:

• All of the following conditions must be met for inclusion:

  1. Age ≥ 65 years;
  2. Symptomatic severe native aortic regurgitation;
  3. Aortic valve anatomy assessed by investigator as suitable for transcatheter aortic valve replacement ;
  4. Subjects signed a written informed consent and agreed to cooperate with all follow-up examinations.

Exclusion Criteria:

• Patients meeting any of the following exclusion criteria were not included:

  1. Active endocarditis;
  2. Acute myocardial infarction or unstable angina pectoris, or severe coronary stenosis requiring coronary revascularization within 3 months;
  3. Stroke or TIA (transient ischemic attack) within the past 3 months;
  4. Any intracardiac mass, left ventricular or atrial thrombus, vegetation detected by echocardiography;
  5. Severe obstructive hypertrophic cardiomyopathy (LVOTG peak ≥ 30 mmHg at rest); Note: Literature Basis: Chinese Guidelines for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy 2023
  6. History of bleeding tendency or coagulopathy or refusal of blood transfusion;
  7. Active gastric ulcer or active gastrointestinal (GI) bleeding within 3 months;
  8. Presence of contraindication to anticoagulation or antiplatelet;
  9. Complicated with severe other valve diseases requiring concurrent surgical intervention;
  10. Prior aortic valve graft (mechanical or bioprosthetic);
  11. Severe left ventricular dysfunction, left ventricular ejection fraction < 30%;
  12. Hepatic encephalopathy or acute active hepatitis;
  13. Renal dysfunction (eGFR < 30ml/min calculated according to Cockcroft-Gault formula) and/or ongoing renal replacement therapy;
  14. Patients with severe dementia and other poor compliance, unable to ensure the completion of the investigator;
  15. Emergency surgery required for any reason;
  16. Known hypersensitivity to contrast agents or nitinol memory alloys or porcine products;
  17. Patients who are pregnant or plan to become pregnant, or are taking estrogen or estrogen-like drugs (women suspected of becoming pregnant must have a negative serum or urine test for human chorionic gonadotropin before being included in the study);
  18. Other patients considered unsuitable for this clinical study by the investigator;