Back to resultsEffect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease (TEEMR)
Primary Purpose
Degenerative Mitral Valve Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RT3D-TEE-guided mitral valve repair
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Mitral Valve Disease
Eligibility Criteria
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
Sites / Locations
- Fuwai Hospital,Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
RT3D-TEE-guided mitral valve repair
Control
Arm Description
Two experienced surgeons and two experienced echocardiography technicians jointly formulated the plan for the TEE-guided mitral valve repair.
Outcomes
Primary Outcome Measures
Composite events of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation
mitral valve repair failure, 1-year reoccurrence of mitral regurgitation
Secondary Outcome Measures
Individual occurrence of composite endpoints of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation
The incidence of secondary transfer, perioperative complications
Intraoperative conditions including extracorporeal circulation time, aortic occlusion time
The recurrence rate of residual mitral valve regurgitation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05595226
Brief Title
Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease
Acronym
TEEMR
Official Title
Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 31, 2021 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sheng Liu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Mitral Valve Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
338 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RT3D-TEE-guided mitral valve repair
Arm Type
Experimental
Arm Description
Two experienced surgeons and two experienced echocardiography technicians jointly formulated the plan for the TEE-guided mitral valve repair.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
RT3D-TEE-guided mitral valve repair
Intervention Description
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 Outcome Measure Information:
Title
Composite events of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation
Description
mitral valve repair failure, 1-year reoccurrence of mitral regurgitation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Individual occurrence of composite endpoints of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation
Time Frame
1 year
Title
The incidence of secondary transfer, perioperative complications
Time Frame
1 year
Title
Intraoperative conditions including extracorporeal circulation time, aortic occlusion time
Time Frame
1 year
Title
The recurrence rate of residual mitral valve regurgitation
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fuwai Hospital,Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng Liu, MD
Phone
86-13501331366
Email
liusheng@fuwai.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease
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