tricuspid regurgitation
Conditions
Interventions
Test group:use of Transcatheter Tricuspid Valve Replacement System
Sponsors
West China School of Medicine/West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: (1) Age = 50 years old; (2) Severe tricuspid regurgitation; (3) There are clinical manifestations of severe tricuspid regurgitation, with NYHA grade = III; (4) Left ventricular systolic function is good (EF = 50%); (5) A high-risk patient assessed by the cardiac team (2 cardiovascular doctors) as unsuitable for surgical surgery, who meets one of the following conditions: (CRS score = 8 points; or STS score>8%; or has 2 or more frailty indices; or has 2 or more major organ dysfunction that cannot be improved after surgery.) (6) Can understand the purpose of the trial and voluntarily participate and sign an informed consent form, Subjects willing to undergo relevant examinations and clinical follow-up
Exclusion criteria
Exclusion criteria: (1) Cardiac ultrasound evaluation of pulmonary artery systolic pressure = 55mmHg; (2) There is significant left ventricular dysfunction (EF<50%); (3) Aortic valve, mitral valve, or pulmonary valve lesions that require surgical intervention; (4) Those who have undergone artificial valve replacement for less than 1 year or have moderate or above artificial valve dysfunction; (5) Congenital Ebstein malformation or right ventricular structural dysplasia; (6) Individuals with right ventricular outflow tract obstruction, active infective endocarditis, or intracardiac masses; (7) Patients with right damaged lung; (8) Severe pleural adhesions on the right side, or inability to separate adhesions through thoracotomy; (9) Individuals with cardiogenic shock or unstable blood circulation; (10) Respiratory failure patients; (11) Severe liver and kidney failure; (12) Severe coronary artery stenosis without surgical or interventional treatment; (13) Those who have experienced cerebrovascular accidents within 3 months; (14) Individuals who develop acute gastrointestinal ulcers or upper gastrointestinal bleeding within 3 months (15) are allergic to aspirin, heparin, clopidogrel, nickel titanium alloy, or contrast agents; (16) Severe Alzheimer's disease; (17) Subjects who are unable to receive anticoagulant or antiplatelet therapy; (18) Expected life = 1 year; (19) Those who participate in clinical trials of other drugs or devices before enrollment but have not yet reached the research endpoint deadline; (20) The researcher judged that the subjects had poor compliance and were unable to complete the study as required; (21) Other situations that the researcher determines are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accumulated all-cause mortality rate at 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate;Surgical success rate;Performance evaluation of implanted valve;Performance evaluation of conveying system;Postoperative cardiac function evaluation;Evaluation of postoperative quality of life;Main adverse event occurrence rate;operative mortality; | — |
Countries
China
Contacts
Public ContactGuo Yingqiang
West China Hospital, Sichuan University
Outcome results
None listed