An Evaluation of the Safety and Performance of the CathVision Cube® System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Recording low-voltage electrograms
研究概览
简要总结
The primary objective is to evaluate the safety and technical performance of the CathVision Cube® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available systems in patients undergoing assessment and ablation of cardiac arrhythmias.
详细描述
A prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the CathVision Cube® system.
Patients undergoing assessment and ablation of cardiac arrhythmias, by Electro Physiology (EP) procedure, and who meet all inclusion criteria will be enrolled in the study and undergo the EP procedure. Intracardiac signals will be passively recorded using the CathVision Cube® System in parallel with a commercial (CE marked) EP recording system and later compared and evaluated. The investigational device will not be used for direct clinical care decisions or therapy. The EP procedure will be guided by the study site Standards Of Care.
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
- •Patient indicated by investigator for catheter ablation or diagnostic electrophysiology procedure.
- •Male or non-pregnant female aged ≥18 years. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
- •Able and willing to directly provide informed consent.
排除标准
- •Patient inability to understand or refusal to sign informed consent.
- •Pregnant or nursing patients and those who plan pregnancy in the period up to 1 month following the index procedure.
- •Current participation in another investigational drug or device study that interferes with this study.
- •Patient is a prisoner.
- •Patients who in the opinion of the physician are not candidates for this study. Prior atrial septal defect (ASD) or patent foramen ovale (PFO) closure with a device using a transcatheter percutaneous approach.
结局指标
主要结局
Recording low-voltage electrograms
时间窗: Duration of the EP procedure can take up to 6 hours
Recording low-voltage electrograms under 20uV amplitude
Freedom from major adverse events, evaluated at hospital discharge.
时间窗: From EP procedure to hospital discharge is 1 day
Freedom from major adverse events, evaluated at hospital discharge
The Primary Performance endpoint of study will be evaluated as technical success of CathVision Cube® system to collect and record intracardiac signals during EP procedures
时间窗: Duration of the EP procedure can take up to 6 hours
Logging time for arrhythmia termination / block
Compatibility of Cube System with commercially available 3D mapping system
时间窗: Duration of the EP procedure can take up to 6 hours
Assessing compatibility of Cube System with commercially available 3D mapping system with available intracardiac catheters. Compatibility is assessed by that the Cube System does not introduce a visual detectable distortion on the commercial available 3D mapping systems
次要结局
未报告次要终点