Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve

Ki vehet részt

• Adults requiring surgical replacement of either mitral or aortic valve
• Capable of undergoing cardiopulmonary bypass
• Able to tolerate anticoagulation therapy
• Able to understand study purpose, willing to provide informed consent and comply with follow-up

Ki nem vehet részt

• History of previous cardiac valve surgery or percutaneous valve replacement, including surgical aortic or mitral valve replacement (excluding Percutaneous Balloon Mitral Valvuloplasty [PBMV], which is permitted)
• Planned concurrent aortic valve surgery or combined valve procedure (e.g., simultaneous aortic and mitral valve surgery)
• Stroke or transient ischemic attack within the prior 3 months
• Myocardial infarction, unstable coronary syndrome, or coronary revascularization within the prior 3 months
• Participation in another interventional clinical trial involving investigational devices or drugs
• Requirement for urgent or emergency cardiac surgery
• Anticipated need for additional non-valve cardiac surgery within 12 months
• Active systemic infection, including pneumonia or infective endocarditis
• Severe comorbidities with expected life expectancy <12 months, including Child-Pugh C liver disease, end-stage malignancy, or advanced pulmonary disease
• History of substance abuse, chronic alcoholism, or significant psychiatric illness impairing study compliance
• Preoperative or intraoperative anatomical unsuitability of the valve apparatus or cardiac structure
• Known allergy or hypersensitivity to polyurethane, polyester, or sulfonate-based biomaterials used in the valve prosthesis
• Left ventricular ejection fraction (LVEF) ≤35%, indicating severe systolic dysfunction
• Severe renal insufficiency, e.g., estimated GFR <30 mL/min/1.73 m² or requirement for chronic dialysis
• Coagulopathy or active bleeding disorders, e.g., INR >1.5 without anticoagulation therapy
• Hematologic abnormalities: hematocrit <30%, hemoglobin <100 g/L, platelet count <100 × 10⁹/L, or WBC <4 × 10⁹/L or >10 × 10⁹/L
• Scheduled coronary artery bypass graft (CABG) during the same admission
• Intracardiac thrombus detected on echocardiography or imaging
• Anatomical risk factors such as ascending aortic aneurysm (≥50 mm), bicuspid aortic valve with ascending aorta ≥45 mm, or other high-risk features identified on imaging
• Withdrawal from the study after valve implantation (such participants are not allowed to re-enroll)