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RecruitingNCT05595226TEEMRUpdated Oct 28, 2022

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

An interventional study of RT3D-TEE-guided mitral valve repair in Degenerative Mitral Valve Disease, sponsored by Sheng Liu. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-10-28.

Sponsored by Sheng Liu · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Dec 2021, registered Oct 2022).
  • Started Dec 2021; still recruiting 4 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
338
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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.

02

Conditions studied

  • Degenerative Mitral Valve Disease

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03

In context

Heart Valve Diseases

535 studies on the registry are indexed under Heart Valve Diseases; 173 are open to participants now.

This study's planned enrollment of 338 is above the median of 100 across 291 interventional studies indexed under Heart Valve Diseases.

Browse Heart Valve Diseases studies →

Lead sponsor

Sheng Liu is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed with chronic primary degenerative mitral regurgitation by the preoperative echocardiogram.
  • Informed consent was obtained

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
338 participants (estimated)

Study arms

  • Experimental
    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.

    Procedure: RT3D-TEE-guided mitral valve repair

  • No intervention
    Control

Interventions

  • ProcedureRT3D-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.

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What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Fuwai Hospital,Chinese Academy of Medical Sciences
    Beijing, Beijing 100044, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05595226
Lead sponsor
Sheng Liu
Responsible party
Sheng Liu (Principal Investigator, Chinese Academy of Medical Sciences, Fuwai Hospital) — Sponsor-investigator
First posted
Oct 26, 2022
Start date
Dec 31, 2021
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 28, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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