About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with chronic primary degenerative mitral regurgitation by the preoperative echocardiogram.
Informed consent was obtained
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
RT3D-TEE-guided mitral valve repair
Procedure/SurgeryRT3D-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.
Treatment groups
Trial outcomes
Primary outcomes
Composite events of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation
mitral valve repair failure, 1-year reoccurrence of mitral regurgitation
Secondary outcomes
Individual occurrence of composite endpoints of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation
The incidence of secondary transfer, perioperative complications
Intraoperative conditions including extracorporeal circulation time, aortic occlusion time
The recurrence rate of residual mitral valve regurgitation
Sponsors and contacts
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Sheng Liu
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor institution