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临床试验/NCT06359678
NCT06359678Unknown不适用

Assessing the Accuracy of Catheter Localization With NorthStar Software in Real-Time MRI-Guided Cardiac Ablation

Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Accuracy of Catheter Localization

研究概览

简要总结

The introduction of real-time MRI-guided cardiac ablation therapy, a significant advancement in interventional medicine, necessitates precise catheter tracking for accurate navigation within the complex cardiac anatomy. The introduction of the NorthStar software as an active tracking system holds promise for improving the precision and efficiency of catheter manipulation during these procedures. However, a rigorous evaluation of its accuracy and reliability in a clinical setting is crucial to validate its viability.

The objective of this study is to evaluate the accuracy of catheter localization using the NorthStar software during real-time MRI-guided cardiac ablation therapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Patients undergoing a real-time MRI-guided flutter ablation procedure at the Amsterdam UMC.

排除标准

  • Lack of legal capacity.
  • Insufficient proficiency in the Dutch language.

结局指标

主要结局

Accuracy of Catheter Localization

时间窗: during procedure

The primary objective of this study is to evaluate the accuracy of catheter localization using the NorthStar software during realtime MRI-guided cardiac ablation therapy. At the start of the procedure, the catheters will be manoeuvred to the predefined areas within the right side of the heart based on the specific electrical signals in that area. These locations will be virtually marked within the NorthStar software. The extent to which these markers maintain their spatial coordinates after the ablation procedure, evaluated by obtained electrical signals, will serve as a quantitative measure of the system's accuracy.

次要结局

  • Influences of breathing pattern(during procedure)
  • Influences of complications during ablation(during procedure)
  • Influences of procedure duration(during procedure)
  • Influences of patient characteristics(during procedure)

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luuk Hopman

Principal Investigator

Amsterdam UMC, location VUmc

研究点 (1)

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