Mitral Regurgitation (MR)NCT07247890
Research on the Development and Application of a Preoperative Assessment Model for Transcatheter Mitral Valve Edge-to-Edge Repair Based on Visual Foundation Models
An observational study of Mitral Regurgitation (MR), run by Beijing Hospital.
Trial summary
Mitral regurgitation (MR) is the most prevalent valvular heart disease in China. Transcatheter edge-to-edge repair (TEER) is currently the preferred treatment for patients with severe MR who face high surgical risks. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mitral Regurgitation (MR)
- What is being tested?
- Model Construction, Validation, and Optimization
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Dec 2027
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population was drawn from Beijing Hospital and Fuwai Hospital of the Chinese Academy of Medical Sciences.
Who may be able to join
- Age: 18-90 years
- Patients with moderate to severe or severe mitral regurgitation as indicated by echocardiography
Who cannot join
- Moderate or severe aortic stenosis or aortic regurgitation, or following aortic valve replacement
- Patients with congenital heart disease
- Poor image quality: Insufficient cross-sectional coverage or inability to perform effective mitral valve marking
About this study
Mitral regurgitation (MR) is the most prevalent valvular heart disease in China. Transcatheter edge-to-edge repair (TEER) is currently the preferred treatment for patients with severe MR who face high surgical risks. However, existing preoperative assessment methods for TEER suffer from numerous limitations, including complex measurement parameters, high technical demands, and significant subjectivity. Vision Mamba, a cutting-edge technology in the visual domain, overcomes the limitations of common computational units in convolutional neural networks and Transformers through bidirectional state space models and positional encoding, demonstrating exceptional performance in visual tasks. To date, no studies have applied Vision Mamba to ultrasound videos for constructing TEER preoperative assessment models. Our team previously established a Transformer-based evaluation model using a small, single-center cohort. This study innovatively introduces a Vision Mamba-based visual foundation model. By integrating multi-faceted, multi-modal ultrasound videos from multiple centers, we develop a one-stop preoperative TEER assessment model for MR patients [slice identification → video analysis → multi-modal information fusion → preoperative assessment recommendation (suitable/challenging/unsuitable)]. This model will optimize surgical patient identification and accurately screen patients with contraindications. Furthermore, the one-stop model is fast and objective, significantly improving clinical efficiency. It holds promise for deployment at primary care levels to optimize healthcare resource allocation.
- Conditions
- Mitral Regurgitation (MR)
- Being tested
- Model Construction, Validation, and Optimization
- Keywords
- Mitral regurgitation (MR), Transcatheter Mitral Valve Edge-to-Edge Repair, Vision Mamba, Visual Foundation Model
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model Construction, Validation, and OptimizationOther
Data from patients in this study will be used for model construction, validation, and optimization.
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiography-related indicators
Measured: Echocardiogram within 2-3 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Regurgitation (MR)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247890
- Sponsor's protocol ID
- 2025BJYYEC-KY205-01
- Status last verified
- Sep 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Development and Application of a Preoperative Assessment Model for Transcatheter Mitral Valve Edge-to-Edge Repair Based on Visual Foundation Models
- ClinicalTrials.gov ID
- NCT07247890
- Acronym / sponsor ID
- 2025BJYYEC-KY205-01
- Conditions
- Mitral Regurgitation (MR)
- Keywords
- Mitral regurgitation (MR), Transcatheter Mitral Valve Edge-to-Edge Repair, Vision Mamba, Visual Foundation Model
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Beijing HospitalOther government
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Nov 2025 (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.
Mitral regurgitation (MR) is the most prevalent valvular heart disease in China. Transcatheter edge-to-edge repair (TEER) is currently the preferred treatment for patients with severe MR who face high surgical risks. However, existing preoperative assessment methods for TEER suffer from numerous limitations, including complex measurement parameters, high technical demands, and significant subjectivity. Vision Mamba, a cutting-edge technology in the visual domain, overcomes the limitations of common computational units in convolutional neural networks and Transformers through bidirectional state space models and positional encoding, demonstrating exceptional performance in visual tasks. To date, no studies have applied Vision Mamba to ultrasound videos for constructing TEER preoperative assessment models. Our team previously established a Transformer-based evaluation model using a small, single-center cohort. This study innovatively introduces a Vision Mamba-based visual foundation model. By integrating multi-faceted, multi-modal ultrasound videos from multiple centers, we develop a one-stop preoperative TEER assessment model for MR patients [slice identification → video analysis → multi-modal information fusion → preoperative assessment recommendation (suitable/challenging/unsuitable)]. This model will optimize surgical patient identification and accurately screen patients with contraindications. Furthermore, the one-stop model is fast and objective, significantly improving clinical efficiency. It holds promise for deployment at primary care levels to optimize healthcare resource allocation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population was drawn from Beijing Hospital and Fuwai Hospital of the Chinese Academy of Medical Sciences.
Key inclusion criteria (2 listed)
- Age: 18-90 years
- Patients with moderate to severe or severe mitral regurgitation as indicated by echocardiography
Key exclusion criteria (3 listed)
- Moderate or severe aortic stenosis or aortic regurgitation, or following aortic valve replacement
- Patients with congenital heart disease
- Poor image quality: Insufficient cross-sectional coverage or inability to perform effective mitral valve marking
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 |
|---|---|---|
| Model Construction, Validation, and OptimizationData from patients in this study will be used for model construction, validation, and optimization. | Other | – |
Primary outcome
Echocardiography-related indicators
Time frame: Echocardiogram within 2-3 days after admission
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 25 Nov 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation (MR), run by Beijing Hospital.
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 3 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: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiography-related indicators (time frame: Echocardiogram within 2-3 days after admission). 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 25 Nov 2025.