Moderate-severe or worse tricuspid regurgitation
Conditions
Interventions
Treatment group:Transcatheter Annuloplasty
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate 1year after operation;Success rate of operation;Success rate of device implantation;Echcardiography;Tricuspid regurgiation Improvement grade decrease;New York Heart Association (NYHA) Classification;6 minutes walk distance;Kansas City Cardiomyopathy Questionnaire;Adverse event;Serious adverse event;Major cardiovascular and cerebrovascular adverse events;Device deficiency;Vital signs;Lab tests; | — |
Countries
China
Contacts
Public ContactJunbo Ge
Zhongshan Hospital affiliated to Fudan University
Outcome results
None listed