aortic regurgitation
Conditions
Interventions
Interventional group:transcatheter aortic valve replacement
Surgical group:surgical aortic valve replacement
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of science and technology
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) The age of subjects = 60 years old; (2) The subjects understood the nature and purpose of the study, voluntarily participated in and signed the informed consent, complied with the test requirements, and agreed to carry out relevant follow-up inquiries and examinations; (3) The subject was clearly identified by echocardiography as having severe aortic regurgitation (or insufficiency), and the degree of regurgitation was = 3+ (i.e., moderate severe or severe); (4) The subject reached the indication of aortic valve replacement surgery: ? symptomatic aortic regurgitation, which refers to the presence of symptoms related to severe aortic regurgitation, such as heart failure, angina pectoris, dyspnea during exercise or at rest, presyncope or syncope; ? Asymptomatic patients had LVEF = 55% or lvesd>50mm or lvesd/bsa>25mm/cm2 (5) The risk of surgical surgery is considered to be medium to high risk by two or more cardiovascular specialists (according to the 2020 ACC/AHA guidelines for the management of patients with valvular heart disease, any of the following criteria are met) :(1) STS score >3%; (2) There are one or more major organ damages that cannot be improved after surgery, such as cardiac dysfunction, renal dysfunction, pulmonary dysfunction, central nervous system dysfunction, gastrointestinal dysfunction, and liver dysfunction; (3) Physical weakness (1 or more of the 7 indicators such as independent walking, independent bathing, independent dressing, independent toileting, independent transfer, independent eating, and incontinence); (4) Factors that have or may have surgical procedure-related obstacles, such as thoracic deformity, after thoracic radiation therapy, severe ascending aorta calcification, tracheotomy, coronary artery bypass grafting, etc. (except for those assessed as extremely high-risk or contraindicated for surgery).
Exclusion criteria
Exclusion criteria: (1) Other serious cardiovascular diseases with surgical indications; (2) End stage heart failure that is also not expected to be reversed by aortic valve surgery; (3) Anatomically, the aortic root is not suitable for transcatheter aortic valve replacement with test products; (4) The conditions of vascular access are not suitable; (5) History of severe acute myocardial infarction or acute cerebrovascular accident within 1 month (excluding lacunar infarction); (6) There are active masses, fresh thrombi or vegetations in the cardiac cavity; (7) Cardiogenic shock, respiratory and circulatory failure, malignant arrhythmia, etc. need mechanical circulatory assistance or emergency surgical rescue; (8) Untreated severe carotid stenosis or bilateral vertebrobasilar stenosis; (9) Other reasons lead to life expectancy less than 1 year, such as active malignant tumors or immune deficiency diseases; (10) Uncontrolled active bleeding or bleeding tendency or severe bleeding disease, or other obvious contraindications to antithrombotic therapy or coagulation disorders; (11) Uncontrolled active infection or active endocarditis; (12) Known to have significant allergic reactions to metals, bovine or porcine substances; (13) The investigator judged that the patients or family members had poor compliance or cognitive impairment (such as coma, Alzheimer's disease, drug abuse), could not meet the requirements or refused to cooperate to complete the follow-up visit; (14) Currently participating in clinical trials of other drugs or medical devices and not reaching the primary endpoint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All cause mortality within 12 months after surgery.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate and surgical success rate;Postoperative cardiac function evaluation; | — |
Countries
china
Contacts
Public ContactDong nianguo
Union Hospital, Tongji Medical College, Huazhong University of science and technology
Outcome results
None listed