mitral regurgitation
Conditions
Interventions
experimental:Mitral Clamping with the PulveClip Transcatheter Mitral Clamp and Delivery System
Sponsors
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1)Patients =18 years of age; 2)Patients with clinical symptoms and echocardiographically confirmed moderate-severe (3+) or severe (4+) chronic mitral regurgitation (MR) (including DMR and FMR1); 3)NYHA cardiac function class II-IV; 4)Left ventricular ejection fraction LVEF = 20%; 5) Anatomically suitable for mitral valve valve repair and evaluated for suitability for use of the study device; 6) If the patient is a DMR it is required to fulfill: A. tendon cable rupture resulting in prolapse; B. surgical high risk as judged by the local clinical trial site cardiac team, with the recommended reference criteria being a surgical valve replacement STS score of =8 or a surgical valve repair STS score of =6 or the presence of other surgical high risk factors (e.g., the presence of =2 indicators of moderate-to-severe weakness or the presence of possible impaired surgical maneuvers or the presence of =2 major organ dysfunction that does not improve in the postoperative period or other surgical high risk factors judged by the cardiac team to determine the presence of other surgical risk factors); To be met if the patient is FMR: A. Symptomatic functional mitral regurgitation FMR (=3+) due to ischemia or non-ischemic cardiomyopathy; B. left ventricular end-systolic internal diameter (LVESD) =70 mm; C. at least one hospitalization for heart failure in the past 12 months and/or subject has a BNP >150 pg/ml,or corrected2 NT-proBNP >600 pg/ml; D. Obtained after stabilization on optimal therapy including Guideline Directed Medical Therapy (GDMT) therapy or after at least 30 days of the following: GDMT dose increase greater than 100% or decrease greater than 50%; coronary revascularization and or implantation of a cardiac resynchronization therapy device (CRT or CRT-D), or reprogramming of an implanted CRT or CRT-D to increase biventricular pacing (from <92% to =92%). E. Moderate-to-severe (3+) or greater regurgitation remains after GDMT; 7) Subjects have been informed of the nature of the study, are able to understand the purpose of the clinical trial, and voluntarily participate and sign an informed consent form. Note 1: FMR requires the presence of global or localized LV wall motion abnormalities that are considered to be the primary cause of MR. Subjects are not eligible if leaflet prolapse or other evidence of degenerative MR is present, even if there is overall or localized LV systolic dysfunction. Note 2: Correction is when the patient's body mass index BMI is above 20 kg/m2, and for every lkg/m2 increase in BMI, the NT-proBNP cutoff is reduced by 4%.
Exclusion criteria
Exclusion criteria: 1) The presence of an intracardiac mass, thrombus, or redundant organism as suggested by echocardiography; 2) Presence of other severe heart valve disease requiring surgical intervention; 3) Postoperative mitral valve surgery or postoperative transcatheter mitral valve surgery; 4) Moderate to severe right heart insufficiency, or elevated pulmonary artery systolic pressure (pulmonary artery systolic pressure PASP > 70 mmHg measured by echocardiography); 5) Acute myocardial infarction within 4 weeks; 6) Any cardiovascular intervention within 30 days; or cardiac surgery within 6 months; or pacemaker therapy or cardiac resynchronization therapy (CRT, CRT-D) or implantation of an implantable cardioverter defibrillator (ICD) within 30 days prior to registration; 7) Presence of contraindications to general anesthesia; 8) End-stage heart failure (ACC/AHA stage D), or after or awaiting heart transplantation; 9) Active endocarditis or active rheumatic heart disease or changes in the mitral valve leaflets (e.g., poor compliance, perforation, etc.) due to endocarditis, rheumatic heart valve disease, or other infections causing bacteremia; 10) History of cerebrovascular accident within 30 days, or severe symptomatic carotid artery stenosis (>70% stenosis on ultrasound); or carotid stenting within 30 days; 11) Peptic ulcer or acute stage of gastrointestinal bleeding; Bleeding disorders or coagulopathies; or contraindication to antithrombotic drug therapy; 13) Modified Rankin Scale score = 4; 14) Diseases that would make evaluation of treatment difficult (e.g., cancer, severe metabolic diseases, psychiatric disorders, etc.); 15) Hemodynamic instability, defined as a systolic blood pressure <90 mmHg without afterload-lowering medications, or cardiogenic shock; or the need for vasoactive drug therapy; or the need for intra-aortic balloon pacing; or other hemodynamic support devices; 16) Hypertrophic cardiomyopathy with or without obstruction, restrictive cardiomyopathy, constrictive pericarditis, infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis, etc.), or other structural heart disease leading to heart failure other than dilated cardiomyopathy; 17) The subject is currently participating in an experimental drug or other device study that has not completed the primary endpoint or would clinically interfere with the endpoints of this study. 18) In the judgment of the investigator, the patient has poor compliance and is unable to complete the study as required; or other circumstances that, in the opinion of the investigator, make the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immediate postoperative device implantation success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate Surgical Success Rate; | — |
Countries
China
Contacts
Public ContactNianguo Dong
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Outcome results
None listed