Valvular heart disease
Conditions
Interventions
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=50 years; 2. Severe tricuspid regurgitation; 3. Clinical manifestation of severe tricuspid regurgitation with NYHA grade >= III; 4. Good left ventricular systolic function with EF >=50%; 5. High-risk patients who were assessed by the heart team (2 cardiologists) as not suitable for surgery, met one of the following conditions: CRS score >=8; or STS score > 8%; or presence of 2 or more frailty indices; or presence of 2 or more major organ dysfunction that could not be improved after surgery; 6. Able to understand the purpose of the trial and voluntarily participate and sign an informed consent form, subjects were willing to undergo relevant examinations and clinical follow-up.
Exclusion criteria
Exclusion criteria: 1. Pulmonary artery systolic blood pressure >=55mmHg was evaluated by echocardiography or right heart catheterization; 2. Patients with artificial valve replacement within 1 year or with moderate or above artificial valve dysfunction; 3. Congenital Ebstein malformation or dysplasia of right ventricular structure; 4. Right ventricular outflow tract obstruction or active infective endocarditis or intracardiac mass; 5. The anatomical structure is not suitable for the transjugular approach; 6. Patients with cardiogenic shock or unstable blood circulation; 7. Patients with respiratory failure; 8. Patients with severe liver and kidney failure; 9. Severe coronary artery stenosis without surgical or personal treatment; 10. Cerebrovascular accidents occurred within 3 months; 11. Patients with acute gastrointestinal ulcer or upper gastrointestinal bleeding within 3 months; 12. Allergy to aspirin, heparin, clopidogrel, Nitinol or contrast agent; 13. Advanced Alzheimer's disease; 14. Subjects unable to receive anticoagulant or antiplatelet therapy; 15. Life expectancy <=1 year; 16. Candidates who have participated in clinical trials of other drugs or devices and have not reached the study endpoint time limit; 17. The researcher judged that the subjects had poor compliance and could not complete the study as required; 18. Other situations in which the researcher judged the candidate unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of immediate surgery;Incidence of complex events 30 days after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of operation;Instrument success rate;Evaluation of performance of implanted valve;Conveying system performance evaluation;Postoperative cardiac function evaluation;Evaluation of postoperative quality of life; | — |
Countries
China
Contacts
Public ContactChen Mao
West China Hospital, Sichuan University
Outcome results
None listed