Mitral regurgitation
Conditions
Interventions
experimental group:Transcatheter valvuloplasty ring system
Sponsors
Department of Cardiology, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1) age =18 years old; 2) symptomatic and transthoracic echocardiography confirmed moderate to severe (3+) or severe (4+) functional mitral regurgitation 3) NYHA class II-IV; 4) The subject has received adequate treatment according to the applicable standards, including treatment for coronary artery disease, left ventricular dysfunction, mitral regurgitation, and heart failure, in the judgment of the study heart team; 5) left ventricular ejection fraction =25% and left ventricular end-diastolic diameter =65mm 6) The subject's femoral vein access was appropriate and transatrial septal puncture was feasible, and the mitral valve was anatomically suitable for mitral annulus repair; 7) with an expected survival time of more than 12 months and compliance with the follow-up plan; 8) The subjects were informed of the nature of the study, understood the purpose of the clinical study, voluntarily participated and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1) active endocarditis; Or valvular leaflet degeneration (such as poor compliance, perforation, etc.) caused by active rheumatic heart disease or rheumatic diseases; 2) The presence of intracardiac mass, thrombus, vegetation, or other anatomical conditions unsuitable for banding therapy according to echocardiography; 3) severe organic lesion with chordae tendineae contracture or congenital malformation with valve tissue loss; 4) heavily calcified annulus or leaflet; 5) other severe valvular heart disease requiring surgical intervention; 6) after mitral valve surgery or transcatheter mitral valve surgery; 7) hypertrophic cardiomyopathy with or without obstruction, restrictive cardiomyopathy, constrictive pericarditis, infiltrative cardiomyopathy (such as amyloidosis, hemochromatosis, granulomatosis, etc.), or other structural heart disease causing heart failure other than dilated cardiomyopathy; 8) acute myocardial infarction or untreated severe coronary stenosis requiring revascularization within 4 weeks; 9) contraindications to transesophageal echocardiography or general anesthesia; 10) end-stage heart failure (ACC/AHA-D stage) after heart transplantation or awaiting heart transplantation; 11) untreated coronary artery disease requiring revascularization; 12) underwent any cardiovascular surgery within 30 days, cardiac surgery within 6 months, pacemaker therapy or cardiac resynchronization therapy (CRT-P, CRT-D) or implantable cardioverter defibrillator (ICD) within 30 days, or patients who met the indications for CRT-P or CRT-D but did not receive implantation; 13) a history of cerebrovascular accident (ischemic) within the past 30 days, unilateral or bilateral severe symptomatic carotid stenosis (> 70% stenosis on ultrasound), or carotid stenting within 30 days, or a history of cerebrovascular accident (hemorrhagic) within 6 months; 14) (estimated glomerular filtration rate (eGFR) 70mmHg on echocardiography) 17) history of acute peptic ulcer or gastrointestinal bleeding within 3 months; 18) hemorrhagic or coagulopathy, or contraindication to antithrombotic therapy; 19) modified Rankin scale score =4 (for patients with a history of cerebrovascular accident); 20) diseases that may cause difficulty in evaluating treatment (e.g., cancer, severe metabolic diseases, psychosis, etc.); 21) plan to become pregnant, pregnant, or breastfeeding; 22) hemodynamic instability defined as systolic blood pressure < without afterload-reducing medications; 90mmHg with symptoms of hypoperfusion, or cardiogenic shock; Vasoactive therapy may be required; Intra-aortic balloon counterpulsation may be required. Or other hemodynamic support devices; 23) active infection requiring concurrent antibiotic treatment (or at least 14 days after discontinuation of antibiotics in the case of transient illness); 24) the participant is currently participating in an investigational trial of an investigational drug or device that has not completed its primary end point or that would clinically interfere with the end point of the study (extended follow-up in a premarketing study of a marketed product is not considered an investigational trial); 25) the investigator judged that the patient had
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of Major Serious Adverse Events (MSAEs) at 30 days after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement from baseline (baseline and 12 months after surgery) in 6-minute Walk Distance;Improvement in changes in quality of life, as assessed by the Kansas City Cardiomyopathy KCCQ score (12 months after surgery);Rate of subjects with postoperative mitral regurgitation (=2+) (discharge, 30 days, 6 months, and 12 months after surgery);Proportion of subjects in NYHA class I or II after surgery (30 days, 6 months, and 12 months after surgery);Success rate of ring adjustment (immediately after implantation);Success rate of ring implantation (immediately after implantation); | — |
Countries
China
Contacts
Public ContactChen Mao
West China Hospital, Sichuan University
Outcome results
None listed