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临床试验/NCT06951126
NCT06951126招募中不适用

CT Prediction for Transcatheter Tricuspid Interventions

Heart and Diabetes Center North-Rhine Westfalia1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Mortality

研究概览

简要总结

The aim of this study is to enhance the predictability of therapeutic success in transcatheter tricuspid valve intervention (TTVI) for patients with severe tricuspid regurgitation (TR). This will be achieved through automated analyses of pre-interventional computed tomography (CT) scans.

Severe tricuspid regurgitation is associated with poor patient outcomes. In advanced stages, pharmacological therapy becomes ineffective, and surgical intervention carries a high mortality risk. Given this clinical challenge, catheter-based treatment of the tricuspid valve has become a focal point of research.

One well-established treatment strategy is percutaneous tricuspid valve intervention, which aims to reduce regurgitation either through annuloplasty, leaflet-based edge-to-edge repair or valve replacement. This approach has been shown to significantly decrease the severity of regurgitation, leading to a dramatic reduction in symptom burden and a marked improvement in quality of life.

However, predicting which patients will benefit most from TTVI and determining the optimal technique for each individual remain largely unresolved challenges.

Artificial intelligence (AI)-powered software, such as heart.ai by LARALAB (Munich), enables automated measurement of anatomical structures captured via CT imaging. This technology already allows for rapid and precise assessment of cardiac chambers and the tricuspid annulus throughout the entire cardiac cycle, facilitating a comprehensive three-dimensional evaluation of right heart anatomy.

To refine patient selection and optimize procedural strategies for TR treatment, the researcher work a multi-center collaboration to analyze treatment outcomes and patient response to specific therapeutic approaches.

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
否

入选标准

  • •the patient underwent full cycle cardiac computed tomography for analysis of valvular heart disease
  • •a transcatheter tricuspid valve intervention is performed
  • •the patient is 18 years or older

排除标准

  • 未提供

结局指标

主要结局

Mortality

时间窗: 1 year

Detection of mortality after transcatheter tricuspid intervention

次要结局

  • Residual Tricuspid Regurgitation(At discharge, 30 days and 1 year)
  • rehospitalization rate(1 year)
  • reintervention rate(1 year)
  • NYHA Class(30 days and 1 year)
  • Intraprocedural success(30 days)

研究者

发起方
Heart and Diabetes Center North-Rhine Westfalia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Johannes Kirchner

Dr. med.

Heart and Diabetes Center North-Rhine Westfalia

研究点 (1)

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