Mitral regurgitation
Conditions
Sponsors
Union Hospital of Fujian Medical University
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 70 mm; 8. primary severe pulmonary hypertension (pulmonary artery systolic pressure >70 mmHg); 9. active bacterial endocarditis; 10. combined aortic stenosis or regurgitation of more than moderate severity; 11. combined with other valvular disease requiring surgery; 12. hypertrophic cardiomyopathy with or without obstruction, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease leading to heart failure other than dilated cardiomyopathy; 13. an acute myocardial infarction within 30 days prior to the procedure 14. a procedure affecting the evaluation of product efficacy such as CABG, valve replacement or repair, pacemaker/defibrillator implantation, etc., within 30 days prior to surgery. 15. Contraindication to anticoagulation; 16. expected survival time = 1 year; 17. Pregnant, lactating women; 18. participating in other clinical trials; 19. Subjects with poor compliance and unable to cooperate with relevant investigations and follow-up; 20. In the opinion of the investigator, unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical success rate 1 month after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate post-operative technique success rate;Mitral valve repair success rate at 12 months postoperatively;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 ContactChen Liang Wan
Union Hospital of Fujian Medical University
Outcome results
None listed