Tricuspid Regurgitation
Conditions
Interventions
intervention group:transcatheter annuloplasty ring system
Sponsors
Department of Cardiology, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Age = 18 years old; 2. With clinical symptoms and transthoracic echocardiography confirmed severe (3+) or above functional tricuspid regurgitation; 3) NYHA New York Heart Function Class II-IVa; 4) In the judgment of the study heart team, the subject has been adequately treated in accordance with applicable standards, including ? Optimized drug therapy for tricuspid regurgitation (eg, diuretics); ? Drugs and/or interventions for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure; 5) Left ventricular ejection fraction = 35%; 6) After evaluation, the subject's femoral vein approach is suitable, and the anatomy of the tricuspid valve is suitable for tricuspid valve annulus repair; 7) High-risk surgical risk: Tri.Score score = 4 points (perioperative mortality rate is 8% and above), or STS score = 8 points (perioperative mortality rate is 8% and above), or the center believes that the patient Not suitable for surgical treatment; 8) The expected survival time is more than 12 months, and the follow-up plan can be followed; 9) The subjects have been informed of the nature of the study, understand the purpose of the clinical study, voluntarily participate and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Active endocarditis; or active rheumatic heart disease or leaflet degeneration caused by rheumatic diseases (such as poor compliance, perforation, etc.); 2) Echocardiography suggests that there is a mass, thrombus or vegetation in the cardiac chamber, or other anatomical conditions that are not suitable for ring constriction therapy; 3) Severe organic disease with chordal contracture or congenital malformation with loss of valve tissue; 4) Severely calcified annulus or leaflets; 5) Severe right heart insufficiency; 6) There are other severe heart valve diseases that require surgical intervention, or other valve surgery or interventional treatment has been carried out within 60 days; 7) After tricuspid valve surgery or tricuspid valve transcatheter surgery; 8) Hypertrophic cardiomyopathy with or without obstruction, restrictive cardiomyopathy, constrictive pericarditis, infiltrating cardiomyopathy (such as amyloidosis, hemochromatosis, granuloma, etc.), or other diseases except dilated cardiomyopathy Structural heart disease leading to heart failure; 9) Acute myocardial infarction occurred within 4 weeks, or untreated severe coronary artery stenosis, requiring revascularization; 10) There are contraindications for transesophageal echocardiography or general anesthesia; 11) End-stage heart failure (ACC/AHA-D stage) requiring intervention (such as left ventricular assist device, heart transplantation), after heart transplantation or waiting for heart transplantation; 12) Percutaneous coronary intervention was performed within 30 days before the operation, except for coronary angiography; 13) Any cardiovascular surgery within 30 days, or cardiac surgery within 6 months, or cardiac pacemaker therapy or cardiac resynchronization therapy (CRT-P, CRT-D) or implantable cardiac surgery within 30 days Cardioverter-defibrillator therapy, or patients who meet the indications of CRT-P and CRT-D but have not been implanted; 14. There is a history of cerebrovascular accident (ischemic) in the past 30 days, unilateral or bilateral severe symptomatic carotid artery stenosis (ultrasound examination shows that the stenosis degree is > 70%), or carotid artery stent implantation has been performed within 30 days, Or a history of cerebrovascular accident (hemorrhagic) within 6 months; 15) Pacing or defibrillation leads may affect device implantation, imaging evaluation or therapeutic effect; 16) Severe chronic obstructive pulmonary disease (suggested by lung function test report, or need for continuous home oxygen therapy or long-term application of steroid hormones) 17) Patients with (estimated) glomerular filtration rate (eGFR) 60mmHg measured by echocardiography); or right heart catheterization (must be performed) pulmonary artery systolic pressure > 70mmHg, or precapillary pulmonary hypertension (average pulmonary artery pressure > 30mmHg) and Transpulmonary pressure > 17mmHg or PVR > 5WU; or when systolic blood pressure > 90 mmHg, PCWP > 18 mmHg (every patient needs to undergo right heart catheterization during the screening period); 20) Severe and uncontrolled hypertension: systolic blood pressure = 180mmHg and or diastolic blood pressure = 110mmHg; 21) History of acute peptic ulcer or gastrointestinal bleeding within 3 months; 22) Severe hepatic insufficiency (Child grade C); 23.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of Major Serious Adverse Events (MSAEs) 30 days after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6 minutes walking distance to improve the situation;Improvement in quality of life from baseline as assessed by the Kansas City Cardiomyopathy (KCCQ) score;Percentage of subjects with postoperative NYHA grade I or II cardiac function;The percentage of subjects with at least 1 grade reduction in postoperative tricuspid regurgitation;Percentage of subjects whose TR rating is reduced to 2 and below;Changes of edema scale grading;The forming ring adjusts the success rate;Success rate of plastic ring implantation; | — |
Countries
China
Contacts
Public ContactChen Mao
West China Hospital, Sichuan University
Outcome results
None listed