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NCT Number: NCT05595226

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

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.

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Key information

Conditions

Degenerative Mitral Valve Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Hospital,Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

Sheng Liu, MD

CONTACT

[email protected]

86-13501331366

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RT3D-TEE-guided mitral valve repair

Procedure

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.

Primary outcomes

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

    Time frame: 1 year

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

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

Sponsors and collaborators

Lead sponsor

Sheng Liu

Other

Registry information

Acronym: TEEMR

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 26, 2022
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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