Degenerative Mitral Valve Disease
Conditions
Brief summary
The aim of this randomized controlled trial to investigate the effects of Real-time 3D transesophageal echocardiography (RT3D-TEE)-guided mitral valve repair on surgical failure and 1-year reoccurrence of mitral valve regurgitation in patients with degenerative mitral value disease.
Interventions
PROCEDURERT3D-TEE-guided mitral valve repair
RT3D-TEE forms a surgical plan before surgery and 3 to 4 senior doctors with more than 50 cases of mitral valve repair perform the procedure.
Sponsors
Sheng Liu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with chronic primary degenerative mitral regurgitation by the preoperative echocardiogram. * Informed consent was obtained
Exclusion criteria
* Re-operation of mitral regurgitation * Concurrent surgical plan for congenital heart disease, coronary artery bypass grafting, aortic valve surgery, radiofrequency ablation of atrial fibrillation and other cardiac surgeries. * Mitral valve replacement * Unable to undergo TEE
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite events of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation | 1 year | mitral valve repair failure, 1-year reoccurrence of mitral regurgitation |
Secondary
| Measure | Time frame |
|---|---|
| Individual occurrence of composite endpoints of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation | 1 year |
| The incidence of secondary transfer, perioperative complications | 1 year |
| Intraoperative conditions including extracorporeal circulation time, aortic occlusion time | 1 year |
| The recurrence rate of residual mitral valve regurgitation | 1 year |
Countries
China
Outcome results
None listed