| Registry | NCT07863531 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, single group, masking: none, prevention |
| Enrollment | 200 (Estimated) |
| Sponsor | Keli Huang (Other) |
| Conditions | Heart Valvular Disease |
| Interventions | Valve repair, Valve replacement (Procedure) |
| Dates | start 2026-11-01 (estimated), primary completion 2026-11-19 (estimated), completion 2030-01-01 (estimated), first posted 2026-10-07, last updated 2026-10-07 |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Valve replacement | Sham comparator | Procedure: Valve replacement | Valve replacement |
| Valve repair | Experimental | Procedure: Valve repair | Valve repair |
Sex: All, ages: 18 Years to 80 Years
Inclusion Criteria: 1. Patients with degenerative mitral regurgitation, rheumatic mitral disease, ischemic mitral regurgitation, or primary and secondary tricuspid regurgitation; 2. Planning to undergo surgical valve repair; 3. Understand the purpose of this trial and voluntarily participate by signing the informed consent form. Exclusion Criteria: 1. Infective endocarditis; 2. Functional valve regurgitation due to atrial fibrillation; 3. Patients with severe and irreversible major organ failure; 4. Combined severe coagulation disorders or obvious bleeding tendencies; 5. Combined malignant tumors; 6. Patients with severe immunological diseases; 7. Pregnant or breastfeeding women, or those planning to conceive during the trial; 8. Severe mental disorders making cooperation impossible; 9. Currently participating in other clinical trials.