Severe or worse tricuspid regurgitation
Conditions
Interventions
Experimental group:The transcaducter tricuspid valve ring system + guidelines guide medication treatment
Sponsors
Zhongshan hospital,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 or above secondary tricuspid regurgitation (secondary tricuspid regurgitation: tricuspid regurgitation caused by right atrial disease, right ventricular cardiomyopathy, right ventricular myocardial infarction, left heart valve disease, congenital heart disease, etc.); (3) A multidisciplinary cardiac team consisting of cardiovascular physicians, cardiovascular surgeons, imaging physicians, anesthesiologists, and at least 2 physicians considered the subjects to be at high risk for surgical procedures, i.e., EuroScore II was greater than 3.0%; (4) left ventricular ejection fraction LVEF = 30%; (5) The subject voluntarily participates in the clinical trial and agrees or his guardian agrees to sign the informed consent; (6) Symptoms of tricuspid regurgitation, such as chest tightness, asthma, shortness of breath, lower limb edema, ascites; (7) NYHA Grades 2 to 4, including Grades 2 and 4; (8) The optimal drug treatment for tricuspid valve =30 days and the patient's state was stable; (9) Patients with mitral regurgitation, atrial fibrillation, coronary artery disease, and heart failure should be treated for =30 days with medication or =30 days after instrument therapy and in stable condition.
Exclusion criteria
Exclusion criteria: (1) Patients with pure organic (i.e. primary) tricuspid regurgitation; (2) Patients with pulmonary artery systolic blood pressure =60 mmHg; (3) Patients with tricuspid valve prosthesis or plastic ring, or patients with tricuspid valve-related surgery; (4) Patients with retrotricuspid annulus calcification; (5) Evidence of intracardiac, jugular and superior vena cava masses, thrombus or growths; (6) Patients with more than moderate aortic stenosis, mitral stenosis, aortic regurgitation, or mitral regurgitation; (7) Patients with severe uncontrolled hypertension (systolic =180 mmHg and/or diastolic=110mmHg); (8) Percutaneous coronary intervention within 1 month; (9) Myocardial infarction or known unstable angina within the previous 1 month; (10) cerebrovascular accidents occurred within the previous 3 months; (11) Patients with active endocarditis or active rheumatic heart disease; (12) Patients with coagulopathy, hypercoagulability or anemia (hemoglobin < 90 g/L); (13) Patients in the acute infection stage 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 raw materials or drugs (such as antiplatelet drugs, anticoagulants); (17) persons addicted to alcohol, drugs or drugs; (18) Patients with cognitive impairment; (19) A history of epilepsy or mental illness with primary and persistent seizures and poor drug control; (20) Participate in any other clinical trial (other than a registered study) within 30 days prior to signing the informed consent; (21) have had a pacemaker (other than a leadless pacemaker) or a defibrillator implanted, or plan to have a pacemaker (other than a leadless pacemaker) or a defibrillator implanted (22) tricuspid stenosis; (23) Ebstain syndrome; (24) esophageal esophageal echocardiography (TEE) and Trans thoracic echocardiography (TTE) were not esophageal esophageal tricuspid ring anatomy; (25) Hemodynamic instability; (26) Patients with chronic dialysis; (27) Women who have planned to become pregnant during pregnancy, lactation or clinical study; (28) Other conditions for which the investigator considers it inappropriate to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects with no all-cause death, no heart failure readmitted, NYHA increased by one grade or more, and TR decreased =1+ within 6 months after randomization;AE/SAE rates; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment success rate 6 months after treatment;Success rate of device implantation (experimental group only);Heart failure readmission rate;Tricuspid valve intervention/re-intervention/surgical rate;Pacemaker implantation rate;The results of echocardiographic evaluation parameters;Improvement rate of tricuspid regurgitation degree;NYHA graded improvement rate of cardiac function;6-MWD;Kansas City Cardiomyopathy Questionnaire, KCCQ score; | — |
Countries
China
Contacts
Public ContactJunBo Ge
Zhongshan Hospital affiliated to Fudan University
Outcome results
None listed