Severe or worse tricuspid regurgitation
Conditions
Interventions
Group 1 :Transcatheter tricuspid annuloplasty
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 60 years old, male or female; 2. Patients with severe and above secondary tricuspid regurgitation (TR >= 4+) (secondary tricuspid regurgitation: right ventricular dysfunction due to right atrial disease, right ventricular cardiomyopathy, right ventricular myocardium Tricuspid regurgitation caused by infarction, left heart valve disease, congenital heart disease and other diseases); 3. A multidisciplinary cardiac team (at least 2 doctors) composed of cardiovascular medicine and cardiovascular surgeons, radiologists, anesthesiologists, etc. believes that the subject is at high risk for surgery, and the EuroScoreII score is greater than 3.0%. Expected May benefit from tricuspid annulus repair; 4. Left ventricular ejection fraction LVEF >= 40%; 5. Subjects voluntarily participate in clinical trials, and agree or their guardians agree to sign the informed consent; 6. Symptoms of tricuspid regurgitation, such as chest tightness, wheezing, shortness of breath, lower extremity edema, ascites; 7. NYHA grade 2 to 4; 8. Receive the best drug therapy for tricuspid valve for >= 30 days and the patient's condition is stable; 9. If the following diseases are combined: mitral valve regurgitation, atrial fibrillation, coronary artery disease and heart failure, drug treatment should be >= 30 days or after device treatment >= 30 days and the patient's condition should be stable.
Exclusion criteria
Exclusion criteria: 1. Patients with purely organic (i.e. primary) tricuspid regurgitation; 2. Patients with pulmonary artery systolic pressure >= 55 mmHg; 3. There are artificial valves or plastic rings in the tricuspid valve position, or patients who have undergone tricuspid valve-related surgery in the past; 4. Patients with posterior tricuspid annulus calcification; 5. There is evidence of mass, thrombus or vegetation in the heart, jugular vein and superior vena cava; 6. Patients with moderate or greater aortic stenosis, mitral stenosis, aortic regurgitation or mitral regurgitation 7. Patients with severe uncontrolled hypertension (systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg); 8. Received percutaneous coronary intervention within 1 month in the past; 9. Myocardial infarction or known unstable angina occurred within 1 month in the past; 10. Cerebrovascular accident occurred within the past 3 months; 11. Patients with active endocarditis or active rheumatic heart disease; 12. Patients with coagulation dysfunction, hypercoagulable state or anemia (hemoglobin < 90 g/L); 13. Patients in the acute infection period or other severe infections; 14. Patients with active peptic ulcer or active gastrointestinal bleeding; 15. Severe end-stage diseases (such as malignant tumors, severe lung diseases, liver diseases, renal failure), with a life expectancy of less than 1 year; 16. Patients with known allergies or contraindications to the raw materials or drugs of the test products (such as antiplatelet drugs, anticoagulant drugs); 17. Alcohol, drug or drug addicts; 18. Patients with cognitive impairment; 19. Those with a history of epilepsy or mental illness; 20. Participate in any other clinical trials (except registration studies) within 30 days before signing the informed consent form; 21. A pacemaker or defibrillator has been implanted in the past, or a pacemaker or defibrillator is planned to be implanted; 22. Tricuspid stenosis; 23. Ebstain syndrome; 24. The anatomy of the tricuspid valve ring cannot be evaluated by Trans esophageal echocardiography (TEE) and Trans thoracic echocardiography (TTE); 25. Hemodynamic instability; 26. Chronic dialysis patients; 27. Women who are pregnant, breast-feeding, or have pregnancy arrangements during clinical research; 28. Other circumstances that the investigator thinks it is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year all-cause mortality after procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Operation sucess rate 12 months after procedure;Device implantation success rate;Results of Echocardiographic Evaluation Parameters;Tricuspid regurgitation improvement grade decrease;New York Heart Function Class Improvement Rate;6-minute walk distance;Kansas City Cardiomyopathy Questionnaire;Adverse Event;Serious adverse event;Major cardiovascular and cerebrovascular adverse events;Device deficiency; | — |
Countries
China
Contacts
Public ContactJunbo Ge
Shanghai Huihe Healthcare Tecnology Co.,Ltd.
Outcome results
None listed