Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation

Inclusion Criteria:

1. Age ≥ 18 years

2. In the judgment of the local cardiac team, the patient has been adequately treatedaccording to applicable standards (including medical management)and has been stablefor at least 30 days.

3. Despite the drug optimization treatment according to the above method, patientsstill have symptoms of TR;

4. Determined by the local cardiac team to be at intermediate or higher risk fortricuspid valve surgery

5. New York Heart Association (NYHA) Cardiac function Class II-IVa;

6. The patient is suitable for transcatheter tricuspid valve repair, suitable for theuse of this study instrument, and the femoral vein access is feasible and canaccommodate catheter; 6. Patient must provide written informed consent before anysteps related to the study.

Exclusion Criteria:

1. Tricuspid valve leaflet anatomy, which may preclude clip implantation, proper clippositioning on the leaflets, including but not limited to the following:

2. Evidence of calcification in the grasping area;

3. Presence of a severe coaptation defect of the tricuspid leaflets;

4. Severe leaflet defect(s) and cleft preventing proper device placementdetermined by ECL;

5. Epstein anomaly.

6. Other serious heart valvular diseases requiring intervention or planning tointervention in the next 12 months; Note: If mitral and tricuspid valve lesions arecombined, mitral valve surgery can be performed first, and re-evaluation can beperformed 60 days after surgery.

7. Tricuspid stenosis evaluated by ECL and/or cross-tricuspid differential pressure ≥ 5mmHg;

8. Previous tricuspid valve surgery or transcatheter therapy;

9. Echocardiography suggested intracardiac thrombus, tumor or mass, or femoral vein andinferior vena cava implants or thrombus;

10. TTE and TEE are unable to evaluate tricuspid valve anatomy; Participated in any drugand/or medical device clinical trials within 1 month prior to the trial; ......

11. The researchers do not consider it appropriate to be enrolled in the study.