Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip TM Transcatheter Annuloplasty System (TriStar)

This is an interventional treatment trial for Tricuspid Regurgitation Read More

Inclusion Criteria:

1. Age ≥60, male or female;
2. patients with severe or above secondary tricuspid regurgitation (TR≥4+) (secondary tricuspid regurgitation: tricuspid regurgitation caused by right atrial lesions, right ventricular cardiomyopathy, right ventricular myocardial infarction, left ventricular valvular disease, congenital heart disease and other diseases);
3. A multidisciplinary cardiac team (at least 2 doctors) consisting of cardiovascular physicians, cardiovascular surgeons, radiologists, anesthesiologists, etc., considered the subject to be at high risk for surgery and expected to benefit from tricuspid valve repair;
4. Left ventricular ejection fraction LVEF≥40%;
5. The subject voluntarily participates in the clinical trial and agrees or his/her guardian agrees to sign the informed consent.
6. Tricuspid regurgitation symptoms, such as chest tightness, asthma, shortness of breath, lower limb edema, ascites;
7. NYHA grade 2 to 4;
8. Patients who received tricuspid valve optimal drug therapy for ≥ 30 days were in stable condition;
9. In the case of the following diseases: mitral regurgitation, atrial fibrillation, coronary disease and heart failure, drug treatment should be ≥ 30 days or ≥ 30 days after instrumental treatment and the patient's condition is stable.

Exclusion Criteria:

1. patients with primary tricuspid regurgitation;
2. Patients with systolic pulmonary artery pressure ≥55 mmHg;
3. Patients with tricuspid valve or annuloplasty or tricuspid related procedure;
4. Patients with posterior tricuspid annulus calcification;
5. Evidence of mass, thrombosis or vegetations in the heart, jugular vein and superior vena cava;
6. patients with moderate or higher aortic stenosis, mitral stenosis, aortic regurgitation or mitral regurgitation;
7. patients with severely uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
8. Percutaneous coronary intervention within 1 month;
9. myocardial infarction or known unstable angina within 1 month;
10. Cerebrovascular accident within the past 3 months;
11. patients with active endocarditis or active rheumatic heart disease;
12. Patients with coagulation dysfunction, hypercoagulability or anemia (hemoglobin < 90 g/L);
13. patients with acute infection or other severe infection;
14. Patients with active peptic ulcer or active gastrointestinal bleeding;
15. severe end-stage diseases (such as malignant tumor, severe lung disease, liver disease, renal failure) with a life expectancy of less than one year;
16. Patients with known allergies or contraindications to the raw materials or drugs (such as antiplatelet drugs and anticoagulants) of the test products;
17. Persons addicted to alcohol, drugs or drugs;
18. Patients with cognitive impairment;
19. patients with histories of epilepsy or mental illness;
20. Participate in any other clinical trial (other than a registry study) within 30 days prior to signing the informed consent;
21. have a previous implantation of a pacemaker or defibrillator, or plan to implant a pacemaker or defibrillator;
22. Tricuspid stenosis;
23. Ebstain syndrome;
24. The anatomy of tricuspid annulus could not be assessed by TEE and TTE;
25. Hemodynamic instability;
26. chronic dialysis patients;
27. women who are pregnant during pregnancy, breast-feeding or during the clinical study;
28. Other conditions that the investigator considers inappropriate for participation in the clinical trial.