NCT06895187尚未招募不适用
Catheter Ablation Using a Novel Navigation and Imaging System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Acute procedural success rates during the index procedure
研究概览
简要总结
The objective of the ENVIsIoN study is to collect data on the use of the VERAFEYE navigation and imaging system in patients indicated to undergo a catheter ablation procedure for the treatment of Paroxysmal Atrial Fibrillation (PAF).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 years of age at the time of consent, or of legal age to give informed consent specific to state and national law
- •Subjects is eligible for a catheter ablation procedure with the VERAFEYE System as navigation and imaging system in the treatment of PAF (according to VERAFEYE System IFUs, current international and local guidelines and per physician discretion)
- •Subject is able to understand and willing to provide written informed consent
- •Subject is able to and willing to complete all study assessments associated with this clinical study at an approved clinical investigational center
排除标准
- 未提供
结局指标
主要结局
Acute procedural success rates during the index procedure
时间窗: During the procedure
A procedure will be defined as successful if all the following conditions occur during the case: * ability to create a 3D anatomical model with the VERAFEYE System and * completion of the necessary ablation applications for PAF using the 3D anatomical model created with the VERAFEYE System
次要结局
未报告次要终点
研究者
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