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Not yet recruitingNCT07247890Updated Nov 25, 2025

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 in Mitral Regurgitation (MR), sponsored by Beijing Hospital. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-11-25.

Sponsored by Beijing Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
800
Ages
18 Years to 90 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Mitral Regurgitation (MR)

Keywords

  • Mitral regurgitation (MR)
  • Transcatheter Mitral Valve Edge-to-Edge Repair
  • Vision Mamba
  • Visual Foundation Model
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In context

Mitral Valve Insufficiency

459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.

This study's planned enrollment of 800 is above the median of 154 across 167 observational studies indexed under Mitral Valve Insufficiency.

Browse Mitral Valve Insufficiency studies →

Lead sponsor

Beijing Hospital is the lead sponsor of 51 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study population was drawn from Beijing Hospital and Fuwai Hospital of the Chinese Academy of Medical Sciences.

Inclusion criteria

  1. Age: 18-90 years
  2. Patients with moderate to severe or severe mitral regurgitation as indicated by echocardiography

Exclusion criteria

Exclusion Criteria:

  1. Moderate or severe aortic stenosis or aortic regurgitation, or following aortic valve replacement
  2. Patients with congenital heart disease
  3. Poor image quality: Insufficient cross-sectional coverage or inability to perform effective mitral valve marking
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
800 participants (estimated)
Target follow-up
2 Days
Patient registry
Yes

Interventions

  • OtherModel Construction, Validation, and Optimization

    Data from patients in this study will be used for model construction, validation, and optimization.

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What researchers measure

Primary outcomes

  1. Echocardiography-related indicators

    Time frame: Echocardiogram within 2-3 days after admission

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07247890
Lead sponsor
Beijing Hospital
Responsible party
Sponsor
First posted
Nov 25, 2025
Start date
Dec 2025 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Nov 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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