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

Not Applicable

Recruiting

• Conditions: Degenerative Mitral Valve Disease
• Interventions: Procedure: RT3D-TEE-guided mitral valve repair

• Registration Number: NCT05595226
• Lead Sponsor: Sheng Liu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-31
• Status Verified: 2022-10
• Study First Submitted: 2022-10-22
• Study First Submitted QC: 2022-10-22
• Study First Posted: 2022-10-26
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-28
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 338

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RT3D-TEE-guided mitral valve repair	RT3D-TEE-guided mitral valve repair	Two experienced surgeons and two experienced echocardiography technicians jointly formulated the plan for the TEE-guided mitral valve repair.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Individual occurrence of composite endpoints of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation	1 year

Trial Locations

Locations (1)

Fuwai Hospital,Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China