Dawneo Neoblazar® Transcatheter Tricuspid Valve Edge-to Edge Repair System Pivotal Clinical Trial in Patients With Severe Tricuspid Regurgitation

Inclusion Criteria:

1. Subjects of age > 18 years;
2. Subjects suffering from severe tricuspid regurgitation (TR≥3+), defined by TTE or TEE;
3. Subject has symptoms with NYHA ≥ Class II-Iva, or at least one hospitalization forsymptoms of heart failure during the past 12 months.
4. Subjects with two cardiac surgeons agreements of contraindications to surgery or highrisk, who meets at least one of the following three conditions: ① Euroscore≥8%； ② Presence of 2 or more Frailty Index； ③ Presence of 2 or more organ insufficiencies。
5. Subjects who's tricuspid valve anatomy are suitable for transcatheter valveedge-to-edge repairment as assessed.
6. Subjects agreeing to the scheduled follow up requirements, who can understand thepurpose of the clinical investigation, and sign voluntarily the informed consent formby themselves and/or the subject' legal guardians.

Exclusion Criteria:

1. Pulmonary artery systolic pressure >70 mmHg measured by transthoracic echocardiographyor right heart catheterization, or irreversible precapillary pulmonary hypertension;
2. The presence of calcification in the grasping area of the tricuspid valve leaflets (including the anterior, septal, and posterior leaflets) that affects clamping, andthe thickness of the tricuspid valve leaflets≥4mm;
3. Severe tricuspid leaflet perforation, cleft or other lesions which preventing theimplantation;
4. Tricuspid valve leaflets coaptation gap >7mm
5. Tricuspid stenosis as assessed by echocardiography (defined as tricuspid orifice area ≤1.0 cm2)
6. LVEF≤20%；
7. Refractory heart failure requiring advanced intervention (e.g., left ventricularassist device, heart transplantation, etc.) (ACC/AHA stage D heart failure);
8. Myocardial infarction or unstable angina within 4 weeks;
9. Untreated severe coronary artery stenosis requiring revascularization;
10. Received percutaneous coronary intervention within 1 month prior to implantation;
11. Severe and uncontrolled hypertension: SBP≥180mmHg or DBP≥110mmHg;
12. Previously implantation of tricuspid valve, annuloplasty ring or accepted tricuspidvalve repair surgery;
13. Pacemaker leads or ICD leads that may affect implantation
14. Complications of other cardiac diseases requiring surgical intervention;
15. Tricuspid leaflet lesions due to rheumatic heart disease (e.g., leaflet grossness,thickening, poor compliance, etc.);
16. Combined with moderate or severer aortic stenosis, aortic regurgitation, mitralstenosis, mitral regurgitation;
17. Congenital Ebstein malformation;
18. Presents of thrombus, vegetation, mass in the right heart system, femoral vein orinferior vena cava, etc.
19. Hemorrhagic disease or hypercoagulable state;
20. Contraindication or allergic reaction to dual antiplatelet agents and anticoagulants;
21. Active infection requiring antibiotic treatment;
22. Renal failure, requiring dialysis treatment;
23. Severe terminal illness (e.g., cancer, etc.) with a life expectancy of less than 1year;
24. Pregnant, lactating women, women preparing to conceive or women of childbearing agewith a positive HCG test (except for women whose medical history describes menopause);
25. Subjects have not met the observed endpoint in other clinical studies in which theyparticipated;
26. Inability to comply with the clinical investigation follow-up or other clinicalinvestigation requirements.