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
- 否
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
研究点 (1)
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