Tricuspid regurgitation
Conditions
Interventions
Single Group:transcatheter tricuspid valve repair system
Sponsors
Department of Cardiology, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Moderate and above (>=2+) tricuspid regurgitation with symptoms; 2. Age >= 18 years old who are not in pregnancy or lactation; 3. Life expectancy >= 12 months; 4. Cardiac function NYHA >= III; 5. Left ventricular ejection fraction (LVEF) >= 50%; 6. According to the investigator's judgment, the patient has received at least 30 days of standard and adequate drug or device treatment, including optimal medical therapy of tricuspid regurgitation (eg. diuretics), treatment of coronary artery disease, mitral regurgitation, atrial fibrillation, and heart failure; 7. According to a multidisciplinary cardiac team (at least one cardiac surgeon and one cardiologist), patients are at high surgical risk or not suitable for routine tricuspid valve surgery; 8. The patient is anatomically suitable for transcatheter tricuspid valve repair and as assessed by the investigator as suitable for the study device; 9. Patients who understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.
Exclusion criteria
Exclusion criteria: 1. Patients with severe and uncontrolled hypertension; 2. Previous cardiac tricuspid valve surgery; 3. Patients with pulmonary hypertension (pulmonary artery systolic blood pressure>50mmHg); 4. Patients with aortic and/or mitral and/or pulmonary valve stenosis and/or regurgitation; 5. Patients with tricuspid valve stenosis (valve area 5mmHg); 6. Pacemaker leads or cardioverter-defibrillator (ICD) leads that would interfere with placement of the tricuspid valve repair system; 7. Patients with active infective endocarditis or other active infections; 8. Patients with Myocardial infarction or unstable angina pectoris within 30 days; 9. Patients with unstable hemodynamics or breathing, requiring continuous mechanical cardiac assistance or mechanical ventilation; 10. Patients with cerebrovascular accident within 3 months, excluding transient ischemic attack; 11. Patients receiving chronic dialysis; 12. Patients with coagulation disorders and severe bleeding disorders; 13. Patients with contraindications or allergies to antiplatelet and anticoagulant drugs; 14. Patients with active peptic ulcer or active gastrointestinal bleeding; 15. Patients with known hypersensitivity to nickel-titanium alloys and contrast agents; 16. Evidences of intracardiac, inferior vena cava or femoral vein masses, thrombus or vegetations; 17. Patients are extremely weak and unable to tolerate general anesthesia surgery or in a state of shock requiring circulatory support; 18. Patients diagnosed with hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis; 19. Imaging examinations suggest that the anatomical structure of the heart and valve is inappropriate. 20. There are other anatomical conditions or other medical, social or psychological conditions that the researchers think may limit the patient's participation in clinical research, compliance with follow-up requirements, or the scientific rationality of the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite rate of all-cause mortality and rehospitalization for heart ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of technical success;Rate of composite endpoint events;Rate of cardiovascular mortality;Rate of severe major adverse events;NYHA classification of cardiac function;Change in severity of tricuspid regurgitation;Change in Quality of life Assessment; | — |
Countries
China
Contacts
Public ContactChen Mao
Outcome results
None listed