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Recruiting Not applicable

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

NCT05595226 · tracked via the Priya Life Science China tracker
Sponsor
Sheng Liu
Phase
Not applicable
Started
2021-12-31
Last updated
2022-10-28

Condition(s) studied

Degenerative Mitral Valve Disease

Investigational drug(s) / intervention(s)

RT3D-TEE-guided mitral valve repair

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Fuwai Hospital,Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05595226 on ClinicalTrials.gov ↗ ← All trials in China