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临床试验/NCT07632794
NCT07632794进行中(未招募)不适用

Artificial Intelligence Semantic Segmentation Technology Assisting Transcatheter Mitral Edgeto-Edge Repair

Mi Chen3 个研究点 分布在 2 个国家目标入组 1,500 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,500
试验地点
3

研究概览

简要总结

This multicenter, retrospective study develops and validates artificial intelligence (AI)-based semantic segmentation algorithms for intraprocedural transesophageal echocardiography (TEE) during Transcatheter Mitral Edge-to-Edge Repair (TEER). Using pooled imaging data from multiple high-volume structural heart centers, the study aims to automate recognition of mitral leaflets and MitraClip components, measure leaflet insertion length in real time, and display clip position and orientation. Algorithm performance will be benchmarked against expert manual annotations.

详细描述

Transcatheter Mitral Edge-to-Edge Repair (TEER) with the MitraClip device is an established minimally invasive treatment for patients with severe mitral regurgitation who are at high surgical risk. The success of TEER relies heavily on real-time transesophageal echocardiography (TEE) to guide precise clip positioning and leaflet capture. However, intraoperative image interpretation remains highly dependent on operator experience, and variability in image quality, patient anatomy, and the dynamic nature of cardiac structures continue to challenge procedural standardization across centers.

This multicenter, retrospective imaging study evaluates whether artificial intelligence (AI)-based semantic segmentation can automate the recognition of mitral valve anatomy and MitraClip device components on intraprocedural TEE images. Previously acquired TEE imaging from adult patients who underwent TEER at multiple participating high-volume structural heart centers will be pooled and analyzed. All data are derived from routine clinical care, and only patients with appropriate consent for research use of their clinical and imaging data are included.

The study has three objectives: (1) to develop deep learning models that automatically segment the anterior and posterior mitral leaflets and the MitraClip grippers and arms; (2) to automate real-time measurement of leaflet insertion length during the grasping process; and (3) to integrate three-dimensional imaging with intelligent tracking to display clip position and orientation. By drawing on a multicenter dataset, the study aims to improve the generalizability and robustness of the resulting models across diverse imaging environments, operator practices, and patient anatomies. Algorithm performance will be benchmarked against expert manual annotations using established image segmentation metrics.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (≥18 years of age) at the time of the index procedure
  • Confirmed diagnosis of degenerative or functional mitral regurgitation
  • Underwent Transcatheter Mitral Edge-to-Edge Repair (TEER) with the MitraClip device at one of the participating centers
  • Intraprocedural transesophageal echocardiographic (TEE) imaging available, complete, and of sufficient quality to support semantic segmentation and real-time measurement analyses
  • Appropriate consent for research use of clinical and imaging data, as per the policy of each participating center

排除标准

  • Incomplete or poor-quality intraprocedural TEE imaging unsuitable for accurate segmentation and measurement
  • Ambiguous or unconfirmed diagnosis of mitral regurgitation
  • Documented refusal to allow use of clinical or imaging data for research purposes
  • Missing essential clinical documentation required to confirm eligibility

研究者

发起方
Mi Chen
申办方类型
Network
责任方
Sponsor Investigator
主要研究者

Mi Chen

Dr.

HerzZentrum Hirslanden Zürich

研究点 (3)

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