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NCT Number: 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

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Model Construction, Validation, and Optimization

Other

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

Primary outcomes

  1. Echocardiography-related indicators

    Time frame: Echocardiogram within 2-3 days after admission

Sponsors and collaborators

Lead sponsor

Beijing Hospital

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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