Degenerative Mitral Valve Disease Clinical Trial
— TEEMROfficial title:
Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease
Verified date | October 2022 |
Source | Chinese Academy of Medical Sciences, Fuwai Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 338 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Fuwai Hospital,Chinese Academy of Medical Sciences | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Sheng Liu |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite events of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation | mitral valve repair failure, 1-year reoccurrence of mitral regurgitation | 1 year | |
Secondary | Individual occurrence of composite endpoints of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation | 1 year | ||
Secondary | The incidence of secondary transfer, perioperative complications | 1 year | ||
Secondary | Intraoperative conditions including extracorporeal circulation time, aortic occlusion time | 1 year | ||
Secondary | The recurrence rate of residual mitral valve regurgitation | 1 year |
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