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

Sheng Liu

Status: Enrolling

Conditions: Degenerative Mitral Valve Disease

Treatments: Procedure: RT3D-TEE-guided mitral valve repair

Study type: Interventional

Funder types: Other

Identifiers

NCT05595226

TEE-MVR Project

Details and patient eligibility

About

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.

Enrollment: 338 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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338 participants in 2 patient groups

RT3D-TEE-guided mitral valve repair

Experimental group

Description:

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

Treatment:

Procedure: RT3D-TEE-guided mitral valve repair

Control

No Intervention group