Feasibility Study of the 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), including:
3. Optimal pharmacological therapy for TR (e.g. diuretics);
4. Drug and/or interventional treatment of mitral regurgitation, atrialfibrillation, coronary artery disease, and heart failure;
5. The Eligibility Committee confirms that the patient has received adequate medicaltreatment.
6. Despite the drug optimization treatment according to the above method, patients stillhave symptoms of TR (TR grade≥3+).
7. New York Heart Association (NYHA) Cardiac function Class II-IVa.
8. The patient is suitable for transcatheter tricuspid valve repair, suitable for the useof the study device, and the femoral vein access is feasible and can accommodate a 24Fcatheter.
9. Patient must provide written informed consent before any steps related to the study.

Exclusion Criteria:

1. Tricuspid valve leaflet anatomy, which may preclude clip implantation or 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 placement determinedby ECL;
5. Epstein anomaly.
6. Previous tricuspid valve surgery or transcatheter therapy.
7. Echocardiography suggested intracardiac thrombus, tumor, or mass.
8. Transthoracic Echocardiogram and Transesophageal Echocardiography are unable toevaluate tricuspid valve anatomy.
9. Refractory heart failure requiring intervention (e.g., left ventricular assist device,heart transplantation) (ACC/AHA Stage D heart failure).
10. Severe and uncontrolled hypertension: systolic blood pressure ≥ 180mmHg and/ordiastolic blood pressure ≥ 110mmHg.
11. Active endocarditis, active rheumatic heart disease, or rheumatic heart valvulardisease leading to tricuspid valve leaf lesions (poor valve leaf compliance,perforation, etc.).
12. Had myocardial infarction or unstable angina within 4 weeks; Untreated severe coronaryartery stenosis requiring revascularization.
13. Percutaneous coronary intervention was performed within 30 days before surgery, exceptfor coronary angiography.
14. Hemodynamic instability, defined as systolic blood pressure < 90mmHg, with or withoutcardiogenic shock, or requiring intra-aortic balloon counterpulsation or otherhemodynamic support devices.
15. Bleeding diseases or coagulation disorders, or antithrombotic drug therapycontraindications.
16. Acute peptic ulcer or gastrointestinal bleeding within 3 months before surgery.
17. Severe cirrhosis (Child's grade C).
18. Allergy to the device material.
19. Life expectancy of fewer than 12 months.
20. Women who are pregnant, breastfeeding, or planning to become pregnant.
21. Participated in any drug and/or medical device clinical trials within 1 month prior tothe trial.
22. The researchers do not consider it appropriate to be enrolled in the study.