Significantly hemodynamically significant tricuspid regurgitation (TR) and venous return
Conditions
Interventions
Experimental group:Perform valve implantation surgery using TricValve? from P F Products Features GmbH, with follow-up of up to 5 years to evaluate the effectiveness and safety of the investigational
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.When signing the informed consent form, the participants must be at least 50 years old; 2.Severe or more severe tricuspid regurgitation diagnosed through transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE) (The severity of tricuspid regurgitation is evaluated according to the 2021 Chinese Expert Consensus); 3.The patient has received standard heart failure medication treatment in accordance with the applicable heart failure guidelines (2023 ESC guidelines) for at least three months. However, after the treatment, there were still recurrent heart failure or edema episodes; 4.NYHA III~IV grade (without the use of strong cardiac drugs: digitalis, dopamine-like drugs, etc.); 5.The high-risk population for tricuspid valve surgery (EuroScore II >= 6% or TriScore >= 6 points, assessed by two cardiologists. In case of inconsistent assessment results, it will be finally determined by a third expert); 6.During right heart catheterization, the average pressure was >= 15 mmHg (measured in the IVC and/or SVC, which are 2-4 cm above or below the inflow tract of the RA); 7.Based on the results of the CT examination, the TricValve instrument is anatomically suitable for use; 8.The preoperative 6-minute walking distance was greater than 60 meters; 9.Be able to understand the purpose of the clinical research, voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Those who had undergone coronary artery bypass grafting surgery or other major cardiovascular surgery within 3 months prior to enrollment, and those who had suffered a myocardial infarction within 30 days prior to enrollment; 2.Within the 3 months prior to enrollment, a stroke occurred (including ischemic stroke, hemorrhagic stroke, and acute stroke of unknown cause, among which the neurological symptoms/signs persisted for >= 24 hours); 3.Those who had digestive tract ulcers or bleeding in the digestive tract within the 6 months prior to enrollment; 4.Within 30 days after the surgery, another planned cardiac operation is scheduled to be carried out, or within 60 days after the surgery, treatment for the aortic valve, mitral valve or pulmonary valve is planned; 5.Echocardiography shows LVEF = 65mmHg (or pulmonary artery systolic pressure >= 65mmHg as determined by right heart catheterization), and moderate or severe tricuspid valve stenosis; 6.Evidence of masses, thrombi or vegetations in the heart, superior vena cava (SVC), inferior vena cava (IVC) or femoral vein; thrombosis of the inferior vena cava filter; right ventricular outflow tract obstruction; or active infective endocarditis or intracardiac masses; cardiogenic shock or unstable blood circulation; type I or II respiratory failure patients; 7.Having vascular diseases (such as stenosis and tortuosity), which makes it impossible to insert the device and establish an intravascular access into the superior vena cava and inferior vena cava; 8.Advanced malignant tumor, terminal state of the tumor, requiring radiotherapy and chemotherapy or for subjects with an expected lifespan of less than 2 years; 9.Platelet count (PLT) less than 75×10^9/L or more than 700×10^9/L, as well as those with contraindications to anticoagulant and antiplatelet therapy and obvious bleeding tendency; 10.Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2; 11.Those with Child-Pugh severity level C (ranging from 10 to 15 points) or suffering from hepatic encephalopathy; 12.Those who are allergic to the components of the test product or have contraindications to CT scans; 13.Active/continuous infections that require the use of antibiotics; 14.Women who are pregnant or breastfeeding as subjects; 15.Participants who use other devices or medications that will directly affect the research treatment or outcome; 16.There are any other factors that other researchers might consider unsuitable for inclusion in this clinical trial or for completion of this clinical trial (such as the presence of mental/behavioral problems).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month all-cause mortality rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate ;Treatment success rate ;The incidence of bleeding;Survival rate ;The incidence of alternative tricuspid valve treatment;The incidence rate of severe heart failure ;Response rate of KCCQ score ;Quality of life and functional indicators ;Clinical and laboratory markers of liver disease ;Echocardiographic indicators ;Computed Tomography (CT) indicators;Body weight and other laboratory markers ;The incidence of MAE;The incidence rate of AE/SAE;Incidence of equipment defects; | — |
Countries
China
Contacts
Public ContactGe Junbo
Zhongshan Hospital, Fudan University
Outcome results
None listed