Mitral Regurgitation
Conditions
Interventions
Control group:Implantation of transcatheter mitral valve clamping device
Sponsors
Xiamen Cardiovascular Hospital Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years old, gender is not limited. 2.Patients with symptomatic moderate to severe degenerative or functional mitral regurgitation (MR >= 3 +) confirmed by transthoracic and/or transesophageal echocardiography (TTE and/or TEE) and planning to undergo transcatheter mitral valve edge-to-edge repair. For degenerative mitral regurgitation (DMR): Patients who are assessed by the cardiac team as being at high risk for surgery (Society of Thoracic Surgeons (STS) predictive mortality risk score for surgical mitral valve replacement >= 8%; or surgical mitral valve repair surgery mortality risk >= 6%; or have other surgical high-risk factors, such as >= 2 frailty indices (moderate to severe frailty); or have possible surgical operational obstacles; or have >= 2 major organ dysfunctions that cannot be improved after surgery; or have other surgical high-risk factors assessed by the cardiac team) or are unwilling to undergo surgery. For functional mitral regurgitation (FMR): After revascularization, cardiac resynchronization therapy (CRT) and other device-assisted therapies or best guideline-guided drug therapy (GDMT) for 1-3 months, there are still symptoms of heart failure (NYHA cardiac function classification III or IVa); At least one hospitalization for heart failure within the past 12 months and/or the subject's brain natriuretic peptide (BNP) > 150pg/ml or brain natriuretic peptide precursor (NT-proBNP) > 600pg/ml; Left ventricular ejection fraction (LVEF) >= 20% and <= 50%, left ventricular end-contraction diameter (LVESD) <= 70mm; 3.The main reflux jet is non-conjunctive and the researchers believe it can be successfully treated (if there is a secondary reflux jet, it should be considered clinically meaningless); 4.Patients who understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to cooperate to complete the follow-up.
Exclusion criteria
Exclusion criteria: 1.Patients with combined rheumatic mitral valve disease. 2.Patients with active infections that cannot be corrected. 3.Patients with severe calcification or significant thickening of anatomical structures in the clamp area are not suitable for TEER. 4.Patients with intracardiac masses, thrombosis, or growths shown on echocardiography. 5.Patients with severe right heart dysfunction (such as lower limb edema with elevated jugular vein pressure and hepatomegaly) or severe pulmonary hypertension (pulmonary artery systolic pressure measured by ultrasound > 70mmHg). 6.Patients with left ventricular ejection fraction (LVEF) 70%) within 30 days before surgery. 13.Patients with hypertrophic cardiomyopathy, restrictive cardiomyopathy, invasive cardiomyopathy (such as amyloidosis, hemochromatosis, sarcoidosis, etc.), constrictive pericarditis, and active endocarditis. 14.Patients with unstable hemodynamics (systolic blood pressure < 90mmHg without the use of afterload-reducing drugs, or cardiogenic shock; or patients who require intra-aortic balloon counterpulsation or other hemodynamic support drugs or devices). 15.Implanted a pacemaker, cardiac resynchronization therapy (CRT), or cardioverter defibrillator (ICD) within 30 days before surgery. 16.Patients with end-stage heart failure (ACC/AHA stage D), heart transplant surgery, or waiting for a heart transplant. 17.Patients who are known to be intolerant to anticoagulants, antiplatelet drugs, or anesthetics, or who are known to be allergic to mitral valve clip components (nickel/titanium, cobalt, chromium, polyester) or who have been evaluated by researchers as severely allergic to contrast agents and cannot undergo surgery. 18.Pregnant or lactating women. 19.Patients who participated in clinical trials of other drugs or medical apparatus did not meet the primary endpoint. 20.Patients considered unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical success rate;Change in Mitral Regurgitation Severity Grade from Baseline: prior to discharge and at 30 days post-procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Major Adverse Events (MAEs) within 30 Days Post-Procedure;Change in NYHA Functional Class from Baseline: at 30 days post-procedure;Mitral Valve Clip Implantation Time;Incidence of All-Cause Mortality within 30 Days Post-Procedure;Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Study Period;Device technical success rate (experimental group only);Fluoroscopy Time;Device Performance Evaluation (experimental group only);Operator Radiation Exposure;Incidence of Device Deficiencies (experimental group only);Clinical Success Rate; | — |
Countries
China
Contacts
Public ContactWang Yan
Xiamen Cardiovascular Hospital Xiamen University
Outcome results
None listed