Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease
TEEMR
1 other identifier
interventional
338
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 31, 2021
CompletedFirst Submitted
Initial submission to the registry
October 22, 2022
CompletedFirst Posted
Study publicly available on registry
October 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
October 28, 2022
October 1, 2022
5 years
October 22, 2022
October 26, 2022
Conditions
Outcome Measures
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
1 year
Secondary Outcomes (4)
Individual occurrence of composite endpoints of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation
1 year
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
Study Arms (2)
RT3D-TEE-guided mitral valve repair
EXPERIMENTALTwo experienced surgeons and two experienced echocardiography technicians jointly formulated the plan for the TEE-guided mitral valve repair.
Control
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosed with chronic primary degenerative mitral regurgitation by the preoperative echocardiogram.
- Informed consent was obtained
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheng Liulead
Study Sites (1)
Fuwai Hospital,Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100044, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 22, 2022
First Posted
October 26, 2022
Study Start
December 31, 2021
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
October 28, 2022
Record last verified: 2022-10