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

This is an interventional treatment trial for Tricuspid Regurgitation Read More

Inclusion Criteria:

1. Age ≥ 18 years

2. In the judgment of the local cardiac team, the patient has been adequately treated according to applicable standards (including medical management), including:

   1. Optimal pharmacological therapy for TR (e.g. diuretics);
   2. Drug and/or interventional treatment of mitral regurgitation, atrial fibrillation, coronary artery disease and heart failure;
   3. The eligibility Committee confirms that the patient has received adequate medical treatment.
3. Despite the drug optimization treatment according to the above method, patients still have symptoms of TR;
4. New York Heart Association (NYHA) Cardiac function Class II-IVa without severe cirrhosis (Child's grade C);
5. The patient is suitable for transcatheter tricuspid valve repair, suitable for the use of this study instrument, and the femoral vein access is feasible and can accommodate 24F catheter;
6. 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, proper clip positioning on the leaflets, including but not limited to the following:

   1. Evidence of calcification in the grasping area;
   2. Presence of a severe coaptation defect of the tricuspid leaflets;
   3. Severe leaflet defect(s) and cleft preventing proper device placement determined by ECL;
   4. Epstein anomaly.
2. Other serious heart valvular diseases requiring intervention or planning to intervention in the next 12 months; Note: If mitral and tricuspid valve lesions are combined, mitral valve surgery can be performed first, and re-evaluation can be performed 60 days after surgery.
3. Tricuspid stenosis evaluated by ECL and/or cross-tricuspid differential pressure ≥ 5 mmHg;
4. Previous tricuspid valve surgery or transcatheter therapy;
5. Echocardiography suggested intracardiac thrombus, tumor or mass, or femoral vein and inferior vena cava implants or thrombus;
6. TTE and TEE are unable to evaluate tricuspid valve anatomy;
7. Left ventricular ejection fraction (LVEF) ≤ 35%;
8. Refractory heart failure requiring intervention (e.g., left ventricular assist device, heart transplantation) (ACC/AHA Stage D heart failure);
9. Pulmonary artery systolic pressure >60 mmHg, or irreversible pre-capillary pulmonary hypertension (iPASP>70mmHg, and PVR>5WU with/without vasodilator challenge), or PCWP is greater than 18mmHg, with a setting-up of a systolic blood pressure greater than 90mmHg) (RHC is required for every patient)
10. Severe and uncontrolled hypertension: systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 110mmHg;
11. Active endocarditis, active rheumatic heart disease, or rheumatic heart valvular disease leading to tricuspid valve leaf lesions (poor valve leaf compliance, perforation, etc.);
12. After ICD surgery, or the pacemaker lead caused TR;
13. Cardiac resynchronization therapy for less than 3 months
14. Had myocardial infarction or unstable angina within 4 weeks; Untreated severe coronary artery stenosis requiring revascularization;
15. Percutaneous coronary intervention was performed within 30 days before surgery, except for coronary angiography;
16. Hemodynamic instability, defined as systolic blood pressure < 90mmHg, with or without cardiogenic shock, or requiring intra-aortic balloon counterpulsation or other hemodynamic support devices;
17. Cerebrovascular accident occurred within 90 days;
18. (estimated) glomerular filtration rate (eGFR) < 25 ml/min or dialysis patients；
19. Bleeding diseases or coagulation disorders, or antithrombotic drug therapy contraindications;
20. Acute peptic ulcer or gastrointestinal bleeding within 3 months before surgery;
21. For active infection, antibiotics should be treated at the same time (for temporary disease, antibiotics should be stopped at least 14 days before patients can be included in the group);
22. Severe cirrhosis (Child's grade C);
23. Severe chronic obstructive pulmonary disease requiring continuous oxygen inhalation;
24. Allergy to the device material;
25. Life expectancy of fewer than 12 months;
26. Women who are pregnant, breastfeeding, or planning to become pregnant;
27. Participated in any drug and/or medical device clinical trials within 1 month prior to the trial;
28. The researchers do not consider it appropriate to be enrolled in the study.