3-Dimensional Simulation Guided Transcatheter Aortic Valve Replacement in Aortic Regurgitation(DIGITAL)

Inclusion criteria

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

• Age ≥ 65 years;
• Symptomatic severe native aortic regurgitation;
• Aortic valve anatomy assessed by investigator as suitable for transcatheter aortic valve replacement ;
• 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:

• Active endocarditis;
• Acute myocardial infarction or unstable angina pectoris, or severe coronary stenosis requiring coronary revascularization within 3 months;
• Stroke or TIA (transient ischemic attack) within the past 3 months;
• Any intracardiac mass, left ventricular or atrial thrombus, vegetation detected by echocardiography;
• Severe obstructive hypertrophic cardiomyopathy (LVOTG peak ≥ 30 mmHg at rest); Note: Literature Basis: Chinese Guidelines for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy 2023
• History of bleeding tendency or coagulopathy or refusal of blood transfusion;
• Active gastric ulcer or active gastrointestinal (GI) bleeding within 3 months;
• Presence of contraindication to anticoagulation or antiplatelet;
• Complicated with severe other valve diseases requiring concurrent surgical intervention;
• Prior aortic valve graft (mechanical or bioprosthetic);
• Severe left ventricular dysfunction, left ventricular ejection fraction < 30%;
• Hepatic encephalopathy or acute active hepatitis;
• Renal dysfunction (eGFR < 30ml/min calculated according to Cockcroft-Gault formula) and/or ongoing renal replacement therapy;
• Patients with severe dementia and other poor compliance, unable to ensure the completion of the investigator;
• Emergency surgery required for any reason;
• Known hypersensitivity to contrast agents or nitinol memory alloys or porcine products;
• 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);
• Other patients considered unsuitable for this clinical study by the investigator;