Severe and above tricuspid regurgitation
Conditions
Interventions
Test group:Tricuspid annulus repair was performed using a transcatheter tricuspid annulus plasty system
Sponsors
Beijing Anzhen Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age >=60 years old, gender not limited; (2) The patient has received adequate treatment with guider-guided medication (GDMT) for tricuspid regurgitation and primary heart disease causing tricuspid regurgitation (if applicable), and the patient's condition has been stable for at least 30 days; The dosage of the drug should remain stable within 30 days, that is, the dosage cannot be increased by more than 100% or decreased by more than 50%. (3) Despite adequate drug treatment, severe or more severe secondary tricuspid regurgitation (TR >=4+) persists; (4) A multidisciplinary cardiology team composed of cardiologists, cardiovascular surgeons, radiologists, anesthesiologists, etc. (at least two doctors) considered that the subjects had a high risk of undergoing surgical operations, that is, a Tri-Score >=6; (5) Left ventricular ejection fraction (LVEF) >=30%; (6) The subjects voluntarily participate in the clinical trial and agree or their guardians agree to sign the informed consent form; (7) Symptoms of tricuspid regurgitation occur, such as chest tightness, shortness of breath, shortness of breath, edema in the lower extremities, and ascites; (8) NYHA grades 2 to 4, including grades 2 and 4; (9) If the following diseases are concurrent: mitral regurgitation, atrial fibrillation, coronary artery disease and heart failure, there should be no indications for surgical or drug intervention.
Exclusion criteria
Exclusion criteria: (1)Patients with simple organic (i.e., primary) tricuspid regurgitation; (2) Patients with more than moderate aortic stenosis, mitral stenosis, aortic regurgitation or mitral regurgitation; (3) Tricuspid stenosis; (4) Ebstain syndrome; (5) Patients with pulmonary artery systolic pressure =60 mmHg; (6) Patients with artificial valves or forming rings at the tricuspid valve position, or those who have undergone previous tricuspid valve-related surgeries; (7) Patients with calcification of the posterior tricuspid annulus; (8) Evidence of masses, thrombi or neoplasms in the intracardiac, jugular vein or superior vena cava; Patients with severely uncontrolled hypertension (systolic blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg); (10) Patients with coagulation dysfunction, hypercoagulable state or anemia (hemoglobin < 90 g/L); (11) Previously implanted pacemakers (except leadless pacemakers) or defibrillators, and it is expected that the implantation of the test device will interfere with the function of such devices, or such devices will affect the implantation or post-implantation effect of the test device, or it is planned to implant pacemakers (except leadless pacemakers) or defibrillators; (12) The anatomical condition of the tricuspid annulus cannot be evaluated by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE). (13) Hemodynamic instability; (14) Where neither the jugular vein nor the femoral vein can be used as an approach; (15) Received percutaneous coronary intervention within the past one month; (16) Myocardial infarction occurred within the past one month or unstable angina pectoris is known; (17) A cerebrovascular accident occurred within the past three months; (18) Patients with active endocarditis or active rheumatic heart disease; (19) Patients in the acute infection stage or with other severe infections; Patients with active peptic ulcers or active gastrointestinal bleeding; (21) Those with severe end-stage diseases (such as malignant tumors, severe lung diseases, liver diseases, and renal failure), and with an expected lifespan of less than one year; (22) Patients with cognitive impairment; (23) Those with a history of primary or persistent seizures of epilepsy or mental illness that have not responded well to drug control; (24) Chronic dialysis patients; (25) Patients who have known allergies or contraindications to the raw materials or drugs of the test product (such as antiplatelet drugs, anticoagulant drugs); (26) Those addicted to alcohol, drugs or narcotics; (27) Have participated in any other clinical trials (excluding registration studies) within 30 days prior to signing the informed consent form; (28) Women who are pregnant, breastfeeding, or in the period of clinical research and have plans to become pregnant; (29) Other circumstances where the researcher deems it inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of device implantation one month after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of device implantation;Treatment Success Rate;Readmission rate for heart failure; | — |
Countries
China
Contacts
Public ContactGuanyuan Song
Beijing Anzhen Hospital, Capital Medical University
Outcome results
None listed