tricuspid valve regurgitation
Conditions
Interventions
experimental group:transcatheter tricuspid valve repair
Sponsors
Internal Medicine-Cardiovascular Department of West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, male or female. 2. The subjects who had received medication still had symptoms and were confirmed by echocardiography as severe tricuspid regurgitation. 3. Patients with NYHA ii-iva or hospitalized with heart failure once or more in the past 12 months. 4. It is suitable for patients with transcatheter tricuspid valve repair and the use of this instrument. 5. According to the judgment of the cardiac surgeon, the estimated risk of death of the patient undergoing tricuspid valve surgery is medium or above, or the local doctor evaluates that the patient is not suitable for thoracotomy. 6. Patients with life expectancy >= 12 months. 7. Subjects who have been informed of the nature of the study, understand the purpose of the clinical trial, voluntarily participate in the trial, agree to its provisions, and have provided written informed consent approved by the ethics committee.
Exclusion criteria
Exclusion criteria: 1. Subjects whose tricuspid valve anatomy is not suitable for device positioning or implantation assessed by the clinical team include but are not limited to the following: (1) Calcification was found in the capture area; (2) The coaptation defect of tricuspid valve was more than 2 cm; (3) Severe tricuspid valve perforation, cleft and other diseases hinder the implantation of the device; (4) Ebstein malformation. 2. Patients with other severe valvular diseases requiring intervention, such as severe aortic stenosis or regurgitation, severe mitral regurgitation. Note: in case of mitral and tricuspid valve disease, mitral valve surgery can be performed first, and trial evaluation can be performed after 60 days. 3. Patients with tricuspid stenosis were defined as tricuspid valve orifice area = 5 mmHg. 4. Patients after tricuspid valve surgery or transcatheter tricuspid valve therapy. 5. Patients with intracardiac thrombus, vegetation or mass indicated by echocardiography; There is implant or thrombus in femoral vein or inferior vena cava. 6. Patients with left ventricular ejection fraction (LVEF) 70mmhg or irreversible pre capillary pulmonary hypertension 9. Patients with severe and uncontrolled hypertension: systolic blood pressure (SBP) >= 180mmhg or diastolic blood pressure (DBP) >= 110mmhg. 10. Patients with active endocarditis, active rheumatic heart disease, or rheumatic heart valve disease leading to tricuspid leaflet lesions (poor leaflet compliance, perforation, etc.). 11. Patients after pacemaker or ICD. Patients with myocardial infarction or unstable angina within 12.4 weeks; Severe coronary artery stenosis without treatment requires revascularization. 13. Patients who had undergone PCI within 30 days before operation. 14. Subjects with hemodynamic instability were defined as systolic blood pressure < 90mmHg, with or without cardiogenic shock or requiring intra aortic balloon counterpulsation or other hemodynamic support devices. 15. Subjects with previous cerebrovascular accident (CVA) within 90 days. 16. Patients with renal failure need dialysis treatment at present. 17. Patients with hemorrhagic disease or hypercoagulable state. 18. Patients with acute peptic ulcer or gastrointestinal bleeding within 3 months before operation. 19. Patients with contraindications or allergic reactions to dual antiplatelet drugs and anticoagulants. Note: antiplatelet drug therapy or anticoagulant drug therapy is contraindicated and is not excluded. 20. Patients with active infection need antibiotic treatment at present. 21. Patients with severe COPD need continuous oxygen inhalation. 22. Patients with known allergy to device materials. 23. Patients with life expectancy less than 12 months. 24. Pregnant, lactating women, women ready to conceive. 25. Patients who participated in any drug and / or medical device clinical trials within one month before this trial. 26. Subjects considered unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30 days Procedure success rate; | — |
Countries
China
Contacts
Public ContactMao Chen
West China Hospital of Sichuan University
Outcome results
None listed