Active valve regurgitation
Conditions
Interventions
Test 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 90 Years
Inclusion criteria
Inclusion criteria: 1) Diagnosis of severe aortic regurgitation by echocardiography; 2) Age = 60 years old; 3) Meets the indications for aortic valve replacement: (1) symptomatic aortic valve regurgitation; (2) No symptoms of heart failure+LVEF65mm or LVESD>50mm or LVESD/BSA>25mm/cm2; 4) Core laboratory evaluation shows that the anatomical structure of the aortic root is suitable for percutaneous TAVR surgery; 5) Patients who, after evaluation by two or more cardiovascular specialists, are deemed unsuitable or intolerant to undergo surgical surgery (meeting any of the following criteria): a. STS score = 6%; b. There are two or more serious irreversible major organ damage, such as heart disease, brain disease, lung disease, liver disease, kidney disease, coagulation disorders, malignant tumors, etc; c. The patient is physically weak and unable to tolerate surgical procedures; d. There are other factors that hinder surgical procedures, such as thoracic deformities, porcelain aorta, and post bypass surgery; 6) Patients who understand the research purpose, voluntarily participate and sign an informed consent form, and are willing to undergo relevant examinations and clinical follow-up
Exclusion criteria
Exclusion criteria: 1) Merge other cardiovascular diseases that require simultaneous surgical surgery, such as aortic dissection, coronary heart disease, and other three vessel lesions; 2) Concomitant moderate or above aortic valve stenosis; 3) Expected life<1 year; 4) Contraindications to antithrombotic therapy; 5) The anatomy and pathological changes of the aortic root are not suitable for artificial valve implantation; 6) Anatomical morphology or vascular diseases that affect instrument access; 7) Left ventricular thrombus; 8) Infectious endocarditis during active phase or other infections that researchers believe affect surgery; 9) Researchers have determined that patients or family members have poor compliance or refusal (such as Alzheimer's disease) and are unable to complete the study as required
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint of all cause death, stroke, and readmission due to heart failure at 1 year after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of complications related to TAVI, including conversion to surgical thoracotomy, unexpected cardiopulmonary mechanical assistance, aortic dissection, coronary occlusion, ventricular septal perforation, mitral valve damage or loss of function, pericardial tamponade, endocarditis, valve heterotopic (displacement, embolism, erroneous release);Reoperation caused by valve dysfunction (TAVI, SAVR, BAV);The incidence of acute kidney injury requiring renal replacement therapy;The incidence of permanent pacemaker implantation;The incidence of severe vascular complications;Valve function evaluation: aortic valve area, average pressure difference across aortic valves, valve regurgitation, and perivalve leakage;New York Heart Association;Immediate instrument success rate after surgery; | — |
Countries
China
Contacts
Public ContactNianguo Dong
Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital
Outcome results
None listed