NCT06056271招募中不适用
Clinical and Healthcare Outcomes From Real-World Use in the United States of a Companion AI During AF Ablation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Primary Clinical Efficacy Outcome
研究概览
简要总结
Observational, multi-center, clinical device registry for US patients with a primary goal to observe the clinical outcomes in patients who are mapped with Volta Medical's VX1 or AF-Xplorer systems during AF ablation procedures.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 21 years of age or older who is:
- •indicated for AF ablation or
- •Who has received an AF-ablation with the past 24 months where VX1 was used or
- •Patients are receiving or received a catheter ablation procedure for AF according to current guidelines
- •Patients must be able and willing to provide written informed consent to participate in the clinical trial
排除标准
- •Patients not indicated or were not indicated for catheter ablation according to current guidelines
- •Patients with AF secondary to an obvious reversible cause
- •Patients who are or may potentially be pregnant
- •Enrollment in an investigational study evaluating another non-VX1 investigational device, biologic, or drug
结局指标
主要结局
Primary Clinical Efficacy Outcome
时间窗: 12 and 24 months
Percentage of subjects free from clinically significant AF or atrial arrhythmia recurrences, after one or multiple ablation procedures, stratified by type of clinical workflow and ablation history.
次要结局
未报告次要终点
研究者
研究点 (4)
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