Tricuspid regurgitation
Conditions
Interventions
Experimental group:Tricuspid annulus repair
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
60 Years to 99 Years
Inclusion criteria
Inclusion criteria: (1) Patient's age = 60 years old, no gender limitation; (2) Patients with moderate to severe or above tricuspid regurgitation (TR=3+) who remained symptomatic despite the best guideline-directed medical therapy; (3) A multidisciplinary heart team consisting of cardiovascular physicians and cardiovascular surgeons, radiologists, and anesthesiologists (at least 2 physicians) considered the study participant to be at high risk for surgery, defined as a EuroScore II score greater than 3.0%; It is expected to benefit from tricuspid annulus repair; (4) Patients with normal left ventricular function (LVEF=40%); (5) The circumferential length of the tricuspid annulus was > 40mm; (6) Mean constriction neck width (VCW) > 7mm or effective backflow area (EROA) > 0.4cm² (7) Study participants volunteered to participate in the clinical trial and agreed or their guardians agreed to sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Severe tegument of tricuspid valve leaflets (Tenting height > 9mm or tenting area=2.1cm² or tenting volume=2.5mL); (2) The right ventricle middle diameter > 38 mm; (3) Tricuspid annular systolic excursion (TAPSE) < 14mm; (4) Patients with pulmonary artery systolic pressure =55 mmHg; (5) Tricuspid position have artificial valve or forming ring, or always of tricuspid valve surgery patients; (6) Evidence of an intracardiac, jugular, or superior vena cava mass, thrombus, or vegetation was present; (7) Patients with moderate or greater aortic stenosis, mitral stenosis, aortic regurgitation, or mitral regurgitation; (8) Patients with severe uncontrolled hypertension (systolic blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg); (9) A percutaneous coronary intervention had been performed within the previous month; (10) A myocardial infarction or known unstable angina had occurred within the previous month; (11) A cerebrovascular accident had occurred within the previous 3 months; (12) Patients with active endocarditis or active rheumatic heart disease; (13) Patients with coagulopathy, hypercoagulability or anemia (hemoglobin < 90 g/L); (14) Patients in the acute phase of infection or other severe infection; (15) Patients with active peptic ulcers or active gastrointestinal bleeding; (16) Severe end-stage disease (such as malignant tumor, severe lung disease, liver disease, renal failure), life expectancy less than 1 year; (17) Patients with known allergies to or contraindications to raw materials or drugs (e.g., antiplatelet agents, anticoagulants) of the trial product; (18) Patients who are addicted to alcohol, drugs or drugs; (19) People with cognitive impairment who are unable to cooperate with the study or follow-up; (20) Associated with epilepsy, or mental illness; (21) Participate in any other clinical trial (other than a registry study) within 30 days prior to signing the informed consent form; (22) Other circumstances that the investigator deemed inappropriate for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of tricuspid regurgitation reduction of at least one grade at 1 month after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Operation success rate;Device implantation success rate (immediately after surgery);Indexes of right heart structural and functional remodeling;The parametric results were evaluated by echocardiography;The rate of improvement in the severity of tricuspid regurgitation;The improvement rate of NYHA cardiac function classification;Six minutes walking distance;Kansas City Cardiomyopathy Questionnaire; | — |
Countries
China
Contacts
Public ContactChen Mao
West China Hospital, Sichuan University
Outcome results
None listed