NCT07353710招募中不适用
A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- The incidence of procedure related serious adverse events and all adverse events
研究概览
简要总结
A first-in-human prospective data collection study including subjects who are planned to undergo an ablation procedure for any atrial arrhythmia as per medical judgement and the site's standard practice, represents the most viable means to collect human anatomy ICE images for the purpose of software development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Subjects who are able and willing to provide written informed consent prior to any study procedure.
- •Subjects who are planned for an ablation procedure for any atrial arrhythmia using any commercially available Boston Scientific Ablation System, per physician's judgement and hospitals' standard practice.
- •Subjects who are willing and able to participate in all testing and assessments associated with this clinical study at an approved clinical investigation center.
- •Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.
排除标准
- •Any of the following cardiac implanted devices
- •Any prosthetic mitral or tricuspid heart valve, such as ring, repairs or clips
- •Atrial septal defect (ASD) occluders including interatrial baffle, closure device, patch, or patent foramen ovale or ASD occluder
- •Subjects with contraindications related to the use of the CHORUS IDx™ System:
- •Subjects with inadequate vascular access
- •Subjects with active systemic infection
- •Subjects with presence of a known intracardiac thrombus in the chamber of use
- •Women who are confirmed to be pregnant or lactating at the time of the Index Procedure
- •Presence of other medical conditions, that, in the investigator's opinion, could limit the subject's ability to participate in the study
- •Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility
研究组 & 干预措施
Treatment
Experimental
Subjects with at least one ICE image collected with the investigational system
干预措施: ICE Image Acquisition (Device)
结局指标
主要结局
The incidence of procedure related serious adverse events and all adverse events
时间窗: 7 Days
Incidence of safety events that have occurred in subjects in whom the investigational device has been inserted, including: * Index Procedure related serious adverse events up to day 7 after the Index Procedure * All adverse events Note: Imaging data will be used for development and validation of the software.
次要结局
未报告次要终点
研究者
研究点 (8)
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