Degenerative Mitral Valve DiseaseTEEMRNCT05595226
Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease
A study testing RT3D-TEE-guided mitral valve repair in people with Degenerative Mitral Valve Disease, run by Sheng Liu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degenerative Mitral Valve Disease
- What is being tested?
- RT3D-TEE-guided mitral valve repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with chronic primary degenerative mitral regurgitation by the preoperative echocardiogram.
- Informed consent was obtained
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital,Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100044
Sheng Liu, MD, 86-13501331366, liusheng@fuwai.com
About this study
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.
- Conditions
- Degenerative Mitral Valve Disease
- Being tested
- RT3D-TEE-guided mitral valve repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT3D-TEE-guided mitral valve repairProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| RT3D-TEE-guided mitral valve repair | Experimental | Two experienced surgeons and two experienced echocardiography technicians jointly formulated the plan for the TEE-guided mitral valve repair. Receives: Procedure: RT3D-TEE-guided mitral valve repair |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite events of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation
mitral valve repair failure, 1-year reoccurrence of mitral regurgitation
Measured: 1 year
Secondary outcomes (4)
Individual occurrence of composite endpoints of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation
Measured: 1 year
The incidence of secondary transfer, perioperative complications
Measured: 1 year
Intraoperative conditions including extracorporeal circulation time, aortic occlusion time
Measured: 1 year
The recurrence rate of residual mitral valve regurgitation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start31 Dec 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Mitral Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheng Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sheng Liu, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595226
- Sponsor's protocol ID
- TEE-MVR Project
- Acronym
- TEEMR
- Status last verified
- Oct 2022
- First submitted
- 22 Oct 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease
- ClinicalTrials.gov ID
- NCT05595226
- Acronym / sponsor ID
- TEEMR / TEE-MVR Project
- Conditions
- Degenerative Mitral Valve Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Sheng LiuUniversity, hospital or other
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT3D-TEE-guided mitral valve repair | Experimental | Procedure: RT3D-TEE-guided mitral valve repairTwo experienced surgeons and two experienced echocardiography technicians jointly formulated the plan for the TEE-guided mitral valve repair. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with chronic primary degenerative mitral regurgitation by the preoperative echocardiogram.
- Informed consent was obtained
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RT3D-TEE-guided mitral valve repairRT3D-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. | Procedure or surgery | RT3D-TEE-guided mitral valve repair |
Primary outcome
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
4 secondary outcomes
Individual occurrence of composite endpoints of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation
Time frame: 1 year
The incidence of secondary transfer, perioperative complications
Time frame: 1 year
Intraoperative conditions including extracorporeal circulation time, aortic occlusion time
Time frame: 1 year
The recurrence rate of residual mitral valve regurgitation
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RT3D-TEE-guided mitral valve repair in people with Degenerative Mitral Valve Disease, run by Sheng Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite events of mitral valve repair failure and 1-year reoccurrence of mitral regurgitation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.