Severe or worse tricuspid regurgitation
Conditions
Interventions
Experimental group:Transcatheter tricuspid valve clips and steerable catheters +GDMT
18/5000
Transcatheter tricuspid valve clip system + guider-guided medication treatment
Sponsors
Zhongshan Hospital Affiliated to Fudan University/Beijing Anzhen Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age =18 years old, gender not limited; 2.According to the judgment of the research team of the center, patients with severe or more severe tricuspid regurgitation (TR=4+) whose related diseases have been fully treated in accordance with the applicable criteria and have been stable for at least 30 days (TR classification is determined by the core experiment); Adequate treatment is defined as: (1) Treatment with oral diuretics for tricuspid regurgitation at a stable dose for at least 30 days; (2) For heart failure (in cases where the subject has concurrent heart failure), use the guidelines based on the type of heart failure with different ejection fractions heart failure drug treatment with a stable dosage for at least 30 days or more; (3)For subjects with mitral regurgitation (MR=3+), atrial fibrillation, or coronary artery disease, drug treatment for = 30 days or device treatment for = 30 days after the operation should be carried out and the patient's condition should be stable. The stable dose is defined as: the dose increase does not exceed 100% or the decrease does not exceed 50%. 3. A multidisciplinary cardiac team (consisting of at least two doctors) composed of cardiologists, cardiovascular surgeons, radiologists, anesthesiologists, etc. considered that the subjects had a medium or high risk of undergoing surgery, that is, a Tri-Score of =4.0%, and determined that the subjects were expected to benefit from the rim-to-edge repair of the tricuspid valve. 4. Left ventricular ejection fraction (LVEF) =20%; 5. Symptoms of tricuspid regurgitation, such as chest tightness, shortness of breath, shortness of breath, edema of the lower extremities, ascites, or asymptomatic but with right ventricular dilation or right ventricular function impairment (determined by the core laboratory); Impaired right ventricular function is defined as: tricuspid annular systolic displacement (TAPSE) <17mm or area change fraction (FAC) <35%. 6. NYHA levels 2 to 4, including Level 2 and Level 4; 7. The subjects voluntarily participate in the clinical trial and agree or their guardians agree to sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. For patients with pulmonary artery systolic pressure =60 mmHg, if right heart catheterization has been performed, the right heart catheterization shall be taken as the standard. If right heart catheterization has not been performed, the ultrasound result shall prevail (determined by the core laboratory). 2. According to the judgment of the core laboratory, the anatomy of the tricuspid valve may prevent the implantation of the tricuspid valve clip, the correct placement on the valve leaflets, the insufficient reduction of the TR grade or the full alignment of the valve leaflets, including but not limited to: (1) There are signs of severe calcification in the lovalle capture area; (2) Severe valve lobe perforation, fissures and other lesions hinder device implantation; (3) Ebstein malformation; (4) It is expected that postoperative TR may not be reduced to 2+ or below through edge-to-edge repair; 3. Patients with artificial valves or forming rings at the tricuspid valve position, or those who have undergone tricuspid valve-related surgeries in the past and whose core laboratory has determined that it will affect the implantation of experimental devices or the therapeutic effect; 4. Tricuspid stenosis is defined as a tricuspid orifine area of =1.0 cm ² and/or an average pressure difference across the tricuspid valve of >5 mmHg (determined by the core laboratory); 5. The anatomical condition of the tricuspid valve cannot be evaluated by transesophageal echocardiography (TEE) or transthoracic wall echocardiography (TTE). 6. Evidence of masses, thrombi or neoplasms in the intracardiac or approaches related veins (jugular vein or femoral vein, depending on the approach chosen for the specific subject), superior vena cava or inferior vena cava (depending on the approach chosen for the specific subject); 7. Patients whose femoral veins in both lower extremities are not suitable for the 23Fr sheath tube approach due to lesions or misformations, and whose bilateral jugular veins are not suitable for the 21Fr sheath tube approach, that is, both cervical and femoral intervention are contraindicated. 8. Patients with severely uncontrolled hypertension (systolic blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg); 9. Previously implanted pacemakers (except leadless pacemakers) or defibrillators (ICDs), or planned implantation of pacemakers (except leadless pacemakers) or defibrillators, and the implanted device has been determined by the core laboratory to affect the implantation of the test device or the treatment effect, or the implantation of the test device will affect the pacemaker or defibrillator; 10. Hemodynamic instability, defined as systolic blood pressure < 90mmHg, cardiogenic shock, requires positive inotropic drugs or intra-aortic balloon counterpulsation or other hemodynamic support devices for treatment; 11. End-stage refractory heart failure requires special intervention (such as mechanical assistance devices, heart transplantation, etc.); 12. Patients with more than moderate aortic stenosis, mitral stenosis, aortic regurgitation, mitral regurgitation, or those planning to undergo heart surgery within the next 12 months; 13. Received percutaneous coronary intervention within the past month; 14. Myocardial infarction occurred within the past one month or unstable angina pectoris is known; 15. A cerebrovascular accident occurred within the past three months; 16. Patients with active endocarditis or active rheumatic he
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of subjects who had no all-cause death or tricuspid valve reoperation, no readmission due to heart failure, and an increase of =15 points in the Kansas City Cardiomyopathy Questionnaire score within one year after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Perioperative success rate; | — |
Countries
China
Contacts
Public ContactGe Junbo, Song Guangyuan
Zhongshan Hospital Affiliated to Fudan University, Beijing Anzhen Hospital
Outcome results
None listed