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NCT05595226 Clinical Trial

Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease

Degenerative Mitral Valve Disease Clinical Trial

— TEEMR  

Official title:
Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05595226
Other study ID # TEE-MVR Project
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 31, 2021
Est. completion date December 31, 2026

Study information
Verified date October 2022
Source Chinese Academy of Medical Sciences, Fuwai Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• RT3D-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.

Locations
Country Name City State
China Fuwai Hospital,Chinese Academy of Medical Sciences Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Sheng Liu

Country where clinical trial is conducted

China, 

Outcome
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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Recruiting NCT03433274 - Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation N/A
Active, not recruiting NCT03674593 - Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae N/A
Terminated NCT04666480 - Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation N/A