Moderate to severe or more severe tricuspid regurgitation
Conditions
Interventions
Transcatheter tricuspid valve group:The transcatheter tricuspid annulus remodeling system is used for treating patients with moderate to severe or more severe tricuspid regurgitation.
Sponsors
The Second Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: The participants in this clinical study must meet all the following inclusion criteria to be enrolled in this study: (1) Age of 60 years or older, regardless of gender; (2) Patients with moderate to severe tricuspid regurgitation (TR >= 3+); (3) A multidisciplinary cardiac team consisting of cardiologists, cardiothoracic surgeons, radiologists, anesthesiologists, etc. (at least 2 doctors) considers that the subject has a high risk for surgical intervention, that is, the EuroScore II score is greater than 3.0%; and it is expected that the subject can benefit from tricuspid annulus repair surgery; (4) Left ventricular ejection fraction (LVEF) >= 40%; (5) The subject voluntarily participates in the clinical trial and agrees or the subject's guardian agrees to sign the informed consent form.
Exclusion criteria
Exclusion criteria: The subjects participating in this clinical study are ineligible for inclusion in this study if they meet any of the following exclusion criteria: (1) Patients with pulmonary artery systolic pressure >= 55 mmHg; (2) Patients with artificial valve or stent ring in the position of the tricuspid valve, or those who have undergone tricuspid valve-related surgery in the past; (3) Patients with evidence of masses, thrombi or vegetations in the intracardiac, jugular vein or superior vena cava; (4) Patients with moderate or higher aortic valve stenosis, mitral valve stenosis, aortic valve regurgitation or mitral valve regurgitation; (5) Patients with severe uncontrolled hypertension (systolic pressure >= 180 mmHg and/or diastolic pressure >= 110 mmHg); (6) Patients who have undergone percutaneous coronary intervention within the past 1 month; (7) Patients who have experienced myocardial infarction or known unstable angina pectoris within the past 1 month; (8) Patients who have experienced cerebrovascular accident within the past 3 months; (9) Patients with active endocarditis or active rheumatic heart disease, with an expected lifespan of less than 1 year; (10) Patients with coagulation dysfunction, hypercoagulable state or anemia (hemoglobin < 90 g/L); (11) Patients in the acute infection period or other severe infections; (12) Patients with active peptic ulcer or active gastrointestinal bleeding; (13) Patients with severe end-stage diseases (such as malignant tumors, severe pulmonary diseases, liver diseases, renal failure), with an expected lifespan of less than 1 year; (14) Patients with known allergies or contraindications to the raw materials or drugs of the test product (such as antiplatelet drugs, anticoagulant drugs); (15) Patients with addiction to alcohol, drugs or narcotics; (16) Patients with cognitive impairment who cannot cooperate with the study or follow-up; (17) Patients with epilepsy or a history of mental illness; (18) Patients who have participated in any other clinical trials (excluding registration studies) within 30 days before signing the informed consent form; (19) Other situations that the investigator deems inappropriate for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The severity of tricuspid regurgitation immediately after the operation decreased by 1+ grade.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical success rate;Success rate of device implantation (immediately after surgery);Results of echocardiographic evaluation parameters;The improvement rate of severe tricuspid regurgitation severity;Improvement rate of NYHA cardiac function classification;Adverse event;Serious adverse event;Major adverse cardiovascular and cerebrovascular events;Defects of the equipment;vital signs;Laboratory examination; | — |
Countries
China
Contacts
Public ContactLi Yan
The Second Affiliated Hospital of Air Force Medical University
Outcome results
None listed