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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSheng Liu

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with chronic primary degenerative mitral regurgitation by the preoperative echocardiogram.

Informed consent was obtained

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • RT3D-TEE-guided mitral valve repair

    Procedure/Surgery

    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.

Treatment groups

338 Participants
are divided into 2 treatment groups
Group A: RT3D-TEE-guided mitral valve repairExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Composite events of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation

mitral valve repair failure, 1-year reoccurrence of mitral regurgitation

Time frame
1 year

Secondary outcomes

1

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

Time frame
1 year
2

The incidence of secondary transfer, perioperative complications

Time frame
1 year
3

Intraoperative conditions including extracorporeal circulation time, aortic occlusion time

Time frame
1 year
4

The recurrence rate of residual mitral valve regurgitation

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sheng Liu

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Sponsor institution