AcQMap 2.1 With Electro-Magnetic Tracking System Feasibility Study (EMT Feasibility Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Successful recording of continuous and synchronized impedance and magnetic localization information.
研究概览
简要总结
Non-Significant Risk Clinical Study
Clinical Investigational Use Only for the purposes of collecting electromagnetic tracking data to validate the use of the device in a clinical setting.
详细描述
The EMT Feasibility Study is a prospective, multi-center, feasibility study designed to demonstrate the feasibility of EMT solution in conjunction with the AcQMap 2.1 System's existing capabilities.
The objective of the study is to demonstrate the ability of the AcQMap 2.1 System to support EMT in conjunction with the existing impedance localization capabilities. The new EMT technology is expected to continuously provide fully synchronized and similar localization information to the impedance-based localization information associated with the location of the catheter's magnetic sensor position.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Male or female 18 years of age or older.
- •Currently scheduled for the ablation of an atrial arrhythmia utilizing the diagnostic AcQMap 2.1 System.
- •Willing and able to give written informed consent.
排除标准
- •In the opinion of the investigator, any contraindication to the planned ablation, including anticoagulation contraindications, atrial thrombus, renal failure, or sepsis.
- •Current enrollment in any study protocol sponsored by Acutus Medical
- •Any other condition that, in the judgment of the investigator, makes the participant a poor candidate for this procedure, the study, or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, extensive travel away from the research center, etc.).
结局指标
主要结局
Successful recording of continuous and synchronized impedance and magnetic localization information.
时间窗: Procedure
Successful recording of continuous and synchronized impedance and magnetic localization information.
次要结局
未报告次要终点