Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter Annuloplasty System

Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter

Evaluate the effectiveness and safety of the transcatheter tricuspid annuloplasty system manufactured by Shanghai Huihe Medical Technology Co., Ltd. for the treatment of patients with moderate-severe or worse tricuspid regurgitation

Inclusion Criteria:

1. Aged 60 or older, regardless of gender;
2. Patients with moderate-severe or worse tricuspid regurgitation (TR≥3+);
3. The multidisciplinary cardiac team (composed of experts in cardiovascular internal medicine and surgery, imaging, anesthesiology, etc. [No. of experts in cardiovascular surgery >=2]) considers the subjects to be at high risk for surgical operation (STS score > 6.0%) and expects that they will benefit from the transcatheter tricuspid annulus repair;
4. Patient with normal left ventricular function (LVEF≥40%);
5. The subject voluntarily participates in the clinical trial and he/she (or his/her guardian) agrees to sign the informed consent form.

Exclusion Criteria:

1. Patients with pulmonary artery systolic pressure ≥55 mmHg;
2. Patients who have a prosthetic valve or annuloplasty ring at tricuspid valve, or who underwent tricuspid valve-related treatment procedure in the past;
3. Evidence of lumps, thrombus or vegetation in the heart, jugular vein, or superior vena cava;
4. Patients with moderate or worse aortic valve stenosis, mitral stenosis, aortic regurgitation or mitral regurgitation;
5. Patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
6. Received PCI less than 1 month ago;
7. MI happened or UAP was found less than 1 month ago;
8. CVA occurred less than 3 months ago;
9. Patients with comorbid active endocarditis or active RHD;
10. Patients with coagulation disorder, hypercoagulable state or anemia (HGB < 90 g/L);
11. Patients with acute infection or other severe infections;
12. Patients with active peptic ulcer or active gastrointestinal bleeding;
13. Patients with severe end-stage diseases (e.g., malignant tumors, severe pulmonary diseases, hepatic diseases, renal failure) whose life expectancy is less than 1 year;
14. Patients with known allergies or contraindications to the raw materials of trial product or the drugs (e.g., antiplatelet drugs, anticoagulant drugs);
15. People who are addicted to alcohol, drugs or narcotics;
16. Patients with cognitive impairment who cannot cooperate with the study or follow-up;
17. Those with a history of epilepsy or mental illness;
18. Participated in any other clinical trials (except for registry studies) less than 30 days before the signing the informed consent form;
19. Other situations that the investigator considers inappropriate for participation in this clinical trial.