Mitral regurgitation
Conditions
Sponsors
Guangdong People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged >= 18 years, no gender limit; 2.Degenerative moderate to severe or severe mitral regurgitation (MR >= 3+); 3.NYHA heart function classification II-IV; 4.High risk or contraindication to extracorporeal circulation as judged by at least 2 surgeons, meeting at least one of the following three conditions: a.Surgical risk STS score >=6%; b.Presence of 2 or more weakness indices; c.Presence of 2 or more organ dysfunctions. 5.Able to understand the purpose of the trial, voluntarily participate and sign an informed consent form, and willing to undergo relevant examinations and clinical follow-ups.
Exclusion criteria
Exclusion criteria: 1.Functional mitral regurgitation; 2.Left ventricular ejection fraction 70mm; 8.Mitral annulus enlargement affects anterior and posterior leaflet docking; 9.Primary severe pulmonary hypertension (pulmonary artery systolic pressure >70mmHg); 10.Active phase of bacterial endocarditis; 11.Combined aortic stenosis or regurgitation of more than moderate severity; 12.Combined with other valve disease requiring surgery; 13.hypertrophic cardiomyopathy with or without obstructive restrictive cardiomyopathy constrictive pericarditis or structural heart disease other than dilated cardiomyopathy leading to heart failure; 14.Acute myocardial infarction within 30 days prior to surgery; 15.Surgery within 30 days prior to surgery that affects product efficacy evaluation e.g. CABG valve replacement or repair surgery pacemaker/defibrillator implantation; 16.Haematological disorders or bleeding disorders or thrombocytopenia (PLT <50×10^9/L) or contraindication to anticoagulation, etc; 17.Expected survival time <= 1 year; 18.Pregnant and lactating women; 19.Currently participating in other clinical trials; 20.Subjects with poor compliance are unable to cooperate with relevant tests and follow-ups; 21.Not considered suitable for this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mitral valve repair success rate at 12 months postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate post-operative technique success rate;Postoperative cardiac function classification at 1, 3, 6 and 12 months;Degree of mitral regurgitation at 1, 3, 6 and 12 months postoperatively;Incidence of surgical procedures due to mitral valve dysfunction at 1, 3, 6 and 12 months postoperatively;Improvement in quality of life at 1, 3, 6 and 12 months after surgery (using the SF-12 Quality of Life Scale);Evaluation of the operational performance of the instruments; | — |
Countries
China
Contacts
Public ContactHuang Huan Lei
Guangdong People's Hospital
Outcome results
None listed