mitral regurgitation
Conditions
Interventions
test group:Implantation of PulveClipTM Transcatheter Mitral Clip and Delivery System
Sponsors
Shenzhen Fu Wai Cardiovascular Hospital,The First Affiliated Hospital of Naval Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age = 18 years; 2) Moderate-severe (3+) or severe (4+) degenerative mitral regurgitation confirmed by echocardiography; 3) Left ventricular ejection fraction =30%, left ventricular end-systolic internal diameter (LVESD) =60mm; pulmonary artery systolic pressure (PASP) =70mmHg, as demonstrated by echocardiography; (4) NYHA cardiac function class II-IV; 5) The patient was assessed by the cardiac team as anatomically suitable for mitral valve repair and suitable for this study device; 6) Surgical high risk as judged by the heart team at the local clinical trial site, 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 frailty or the presence of possible barriers to surgical maneuvering or the presence of =2 major organ dysfunctions that do not improve in the postoperative period or other surgical high risk factors judged to be present by the cardiac team to determine the presence of other surgical risk factors); 7) Subjects were willing and complied with the protocol requirements and data collection procedures; were able to understand the purpose of the trial, and that they or their legal guardian voluntarily participated and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1) History of previous mitral valve surgery or heart transplantation; 2) Severe organ dysfunction that may affect study evaluation, including but not limited to: a) Right heart failure or total heart failure; b) Severe restrictive obstructive pulmonary disease (COPD) requiring continuous oxygen therapy or oral hormone therapy; c) Severe renal insufficiency requiring or likely to require continuous renal replacement therapy (CRRT) or dialysis postoperatively; d) Severe carotid artery stenosis, confirmed by imaging to be more than 70%; 3) History of cerebrovascular accident within 1 month prior to surgery; 4)acute myocardial infarction within 1 month prior to surgery; 5)history of acute deep vein thrombosis or acute pulmonary embolism; 6)any known active infection; 7)active infective endocarditis (can be enrolled after 6 weeks of standard anti-infective therapy), or rheumatic heart valve disease, or radiographic valve lesions; 8)History of cardiac or macrovascular surgical or interventional procedures within 30 days (coronary angiography can be enrolled); 9)Combination of any other valve disease of more than moderate severity (aortic, tricuspid, pulmonary stenosis or insufficient closure); 10)other cardiac and macrovascular diseases known to require surgical or interventional intervention, including but not limited to coronary artery disease, cardiomyopathy, aortic disease, etc. (except for coronary angiography); 11) The presence of an intracardiac mass, thrombus, or redundant organism confirmed by ultrasound, or a mitral valve orifice area (MVOA) = 4.0 cm2, or any condition that makes the use of an investigational device inappropriate, including but not limited to: a) Unsuitability of the leaflet free edge for grasping (e.g., presence of severe calcification or clefts); b) Lack of primary and secondary tendon cord support in the grasping area; c) The length of the leaflet free edge is <0.8 cm. 12) Any condition known to limit the ability to perform the study procedure (including, but not limited to, allergy to study device components; coagulation disorders; life expectancy <1 year, etc.); 13)Hemodynamic instability, defined as systolic blood pressure <90 mmHg without afterload-lowering medications, or cardiogenic shock; or need for vasoactive drug therapy; or need for intra-aortic balloon pacing; or other hemodynamic support devices; 14)Pregnant or lactating women, or planning a pregnancy during the trial period; 15)Participating in another clinical trial that has not yet reached the trial endpoint; 16) other conditions that, in the judgment of the investigator, make participation in this study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effectiveness at 12 months ± 30 days postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate postoperative instrumentation success rate;Surgical success rate;Clinical efficiency at 30 days ± 7 days postoperatively and 6 months ± 15 days postoperatively;Improvement in New York Heart Association (NYHA) cardiac function classification before discharge, 30 days ± 7 days postoperatively, 6 months ± 15 days postoperatively, 12 months ± 30 days postoperatively;Quality of life measured at 30 days ± 7 days postoperatively, 6 months ± 15 days postoperatively, and 12 months ± 30 days postoperatively SF36;KCCQ score at 30 days ± 7 days postoperatively, 6 months ± 15 days postoperatively, and 12 months ± 30 days postoperatively;6-minute walk test at 30 days ± 7 days postoperatively, 6 months ± 15 days postoperatively, and 12 months ± 30 days postoperatively;Left ventricular function (LVEF left ventricular ejection fraction, LVEDV left ventricular end-diastolic volume, LVESV left ventricular end-systolic volume, LVIDs left ventricular end-systolic internal diameter, LVIDd left ventricular end-diastolic internal diameter) at 30 days ± 7 days postoperatively, 6 months ± 15 days postoperatively, and 12 months ± 30 days postoperatively;Rehospitalization for heart failure at 30 days ± 7 days postoperatively, 6 months ± 15 days postoperatively, and 12 months ± 30 days postoperatively;Evaluation of instrument performance; | — |
Countries
Chnia
Contacts
Public ContactXiangbin Pan/ Yongwen Qin
Shenzhen Fu Wai Cardiovascular Hospital/ The First Affiliated Hospital of Naval Medical University
Outcome results
None listed