Automated Assessment of Pulmonary Vein Isolation (PVI) Using a Novel EP Recording System (CathVision Cube® System)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 8
- 主要终点
- PVI Analyzer Safety Profile, Measured as the Number of Adverse Events and/or Device Malfunctions.
研究概览
简要总结
A prospective, multi-center study with the CathVision Cube® system and the PVI Analyzer software in radiofrequency (RF), cryo-balloon (CB), and Pulse Field Ablation (PFA) procedures.
详细描述
Subjects with paroxysmal or persistent atrial fibrillation (AF) who are indicated to undergo first pulmonary vein isolation (PVI) procedure and meet all eligibility criteria will be enrolled in the Study. Intracardiac signals will be passively recorded using the investigational CathVision Cube® System in parallel with the conventional (CE marked) EP recording system. The investigational device will not be used for direct clinical care decisions or therapy. The validation of the automated algorithm for PVI will be performed offline
The primary objective is to validate the PVI Analyzer software with a novel EP recording system (CathVision Cube® System) for assisting assessment of isolation status following PVI ablation.
The secondary objective is to determine the feasibility of "real-time" assessment of PVI analysis and rhythm dependent performance using the PVI Analyzer and CathVision Cube® System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
PVI Analyzer Safety Profile, Measured as the Number of Adverse Events and/or Device Malfunctions.
时间窗: From EP procedure until study completion at discharge; an average of 24 hours.
As part of the primary outcome, safety is also evaluated as the number of adverse events and device malfunctions reported by the study team at site, during the use of the CathVision Cube® System from the start of the procedure until discharge. The number of adverse events and device malfunctions is recorded in the site's source documents as well as in the case report form (CRF) and is duly informed to the Sponsor who also keeps the record.
PVI Analyzer Sensitivity and Specificity, Measured as the Accuracy of Predictions for Non-isolated and Isolated Veins.
时间窗: From EP procedure until study completion at discharge; an average of 24 hours.
The primary outcome is to evaluate the sensitivity and specificity of the PVI Analyzer in the classification of the isolation status of veins, following the medical procedure known as pulmonary vein isolation (PVI). The information used for this has been obtained from the investigational CathVision Cube System. The PVI Analyzer determines whether the veins are isolated or not after pulmonary vein ablation. The proportion of correct negative (non-isolated) predictions among non-isolated vein data points and the proportion of correct positive (isolated) data points from isolated veins, provide the sensitivity and specificity data, respectively.
次要结局
- Feasibility of "Real-time" Assessment of Isolation, Measured by Retesting the Accuracy of the PVI Analyzer Classification of Isolation Status at Different Timepoints Before, During and After Ablation.(From EP procedure until study completion at discharge; an average of 24 hours.)
- PVI Isolation Classification in Non-sinus Rhythm (NSR) From EP Procedure(From EP procedure until study completion at discharge; an average of 24 hours.)
- Accuracy of PVI Analyzer Classification at the Time of Expert-defined Isolation(From EP procedure until study completion at discharge; an average of 24 hours.)
- The Pulmonar Vein Isolation (PVI) Classification in Sinus Rhythm (SR) Considering the Electrophysiology Procedure Type.(From EP procedure until study completion at discharge; an average of 24 hours.)
- Comparison of the PVI Analyzer Performance With CathVision Cube® System Data With Its Performance With Data From Other Conventional EP Systems Used(From EP procedure until study completion at discharge; an average of 24 hours.)