Clinical Research Directory

Multi-center Research Clinical Trial Protocol for Etiology-pathology and Repair Classification of Mitral and Tricuspid Valves

Sponsor: Keli Huang

Summary

The choice of valve repair is very important in the treatment of cardiac valve disease, and its core is the etiology pathology analysis, which directly determines the design of repair strategy and the quality of postoperative effect. There are significant differences in anatomic structure, dysfunction and pathological characteristics of valve lesions caused by different etiologies. Therefore, accurate etiological pathological evaluation is the basis for the selection of surgical procedures. This topic focuses on degenerative, rheumatic, ischemic mitral valve disease and primary and secondary tricuspid valve disease. Around the common bottleneck problems of unclear repair scope of plastic surgery, high conversion valve rate, and high heterogeneity of clinical operation, Delphi method is used to demonstrate the implementation experience and key points of etiology pathology surgery correlation classification; Guided by the principle of restoring the physiological matching between the valve annulus and the valve leaflet as much as possible, and based on the implementation of the scientific prism framework, the technologies such as valve leaflet repair, edge to edge, artificial chordae and shaped ring implantation were combined with UCG decision-making information. With the goal of valve leaflet closure height of 5-10mm, constriction neck less than 3mm, one-time manual success rate of more than 90%, conversion valve rate of less than 2%, and reoperation rate of less than 2% within 6 months, 200 cases of multi center clinical implementation scientific research were carried out to verify the corresponding relationship between implementation experience and key points and application, establish evidence-based transplantable surgery strategies and form operation technical specifications.

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