Aortic Regurgitation
Conditions
Interventions
Treatment group:transcatheter aortic valve replacement
Sponsors
Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Subjects were = 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 diagnosed with moderate severe or severe aortic regurgitation (or regurgitation) by echocardiography; (4) The subject reached the indication of aortic valve replacement surgery: ? symptomatic aortic regurgitation with heart failure; ? Patients without heart failure symptoms had LVEF = 50%, LVESD > 50mm, lvesd/bsa > 25mm/cm2, or LVEDd = 60mm; (5) Evaluate the patients' high-risk, unfit or intolerant surgical operation; (6) Preoperative assessment of the patient's vascular approach and aortic root anatomic conditions were suitable for transcatheter aortic valve replacement.
Exclusion criteria
Exclusion criteria: (1) Other cardiovascular diseases with surgical indications and requiring simultaneous surgical intervention, such as severe organic mitral regurgitation or mitral stenosis, aortic dissection, aortic root aneurysm, three vessel coronary artery disease, congenital heart defects, etc; (2) Heart failure that is also not expected to be reversed by aortic valve surgery; (3) The lesion is not suitable or anatomically unable to complete transcatheter aortic valve replacement; (4) History of severe myocardial infarction or stroke within 1 month; (5) Respiratory and circulatory failure that is difficult to maintain vital signs; (6) The life expectancy is less than 1 year due to other reasons; (7) Active bleeding or bleeding tendency, coagulation disorder, or other contraindications to antithrombotic therapy; (8) Uncontrolled active infection; (9) Known to have significant allergic reactions to nitinol or bovine pericardial material; (9) The investigator judged that the patients or family members had poor compliance (such as senile dementia), could not meet the requirements or refused to cooperate to complete the follow-up visit of the study; (10) Currently participating in clinical trials of other drugs or medical devices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mortality;success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of valve function indexes;Postoperative cardiac function evaluation; | — |
Countries
China
Contacts
Public ContactDong Nianguo
Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital
Outcome results
None listed