跳至主要内容
临床试验/NCT04841382
NCT04841382终止不适用

Physician Assessment of the Clinical Utility of a Patient-Specific 3D Electro-Anatomical Heart Model in VT Ablation

CardioSolv Ablation Technologies1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
1
试验地点
1
主要终点
Time to Receipt of 3D Heart Model

研究概览

简要总结

ACE-VT is a clinical pilot study designed to evaluate the ability of the CardioSolv Software System to generate an output for the physician to review in a timely fashion, consistent with the standard of care VT ablation workflow. This study will assess the acute effectiveness of using the CardioSolv Software System output as additional supporting information during ablation.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant meets standard criteria for VT ablation and is scheduled for VT ablation by their cardiologist or electrophysiologist
  • 18 to 85 years of age
  • VT and ischemic cardiomyopathy
  • A pre-procedure MRI with LGE is available (performed within 1 year of procedure, unless an MI has occurred since MRI) with adequate image for analysis
  • Participant is able and willing to provide written informed consent

排除标准

  • Contradiction to MRI (except those with MRI compatible pacemaker/ICD/CRT devices implanted or site has approved procedure for MRI of non-compatible devices).
  • Participant implanted with an LVAD.
  • Enrolled in another non-imaging intervention assignment study that could confound the results of this study.

结局指标

主要结局

Time to Receipt of 3D Heart Model

时间窗: 24 hours

Verify that the CardioSolv Software System is able to receive and process input data and generate the expected output available for viewing by the physician in less than 24 hours.

次要结局

未报告次要终点

研究者

发起方
CardioSolv Ablation Technologies
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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