Evaluation of the Safety and Effectiveness of the Circle SAFE System for Diaphragmatic Compound Motor Action Potential (CMAP) Recording and Display of Patients Undergoing Pulmonary Vein Ablation Procedures. The SAFE-CMAP Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Freedom from device-related Major Adverse Events (MAEs) through hospital discharge. MAEs are defined as major thromboembolic events, vascular damage requiring surgical intervention, tamponade, perforation and ischemic stroke attributable to the device
研究概览
简要总结
The objective of this first-in-human study is to evaluate the safety and performance of the Circle Safe System in subjects undergoing pulmonary vein ablation for atrial fibrillation.
The main questions it aims to answer are:
- Can the Circle Safe System consistently stimulate the phrenic nerve and record a stable electrical response from the diaphragm?
- Can it reliably display changes in the diaphragm's response during ablation?
- What device-related or procedure-related medical problems occur during the study? There is no comparison group. All participants will undergo their planned pulmonary vein ablation while the Circle Safe System is used during treatment of the right pulmonary veins.
Participants will:
- Complete standard assessments before the procedure
- Have the Circle Safe catheter placed in the superior vena cava during the ablation procedure
- Have their phrenic nerve stimulated and their diaphragm response monitored using the Circle Safe System
- Be evaluated for device-related and procedure-related safety events through hospital discharge
详细描述
During right pulmonary vein ablation, the Circle Safe catheter is advanced through the venous system and positioned in the superior vena cava. Its distal electrodes provide diagnostic stimulation of the right phrenic nerve, while its proximal electrodes record the resulting diaphragmatic compound motor action potential (CMAP).
The recorded signal is transmitted to the Circle Safe System Console, which displays the CMAP waveform and automatically compares its amplitude with a baseline measurement obtained before ablation. This allows changes in diaphragmatic activity to be monitored throughout treatment of the right pulmonary veins.
The Circle Safe System is a diagnostic monitoring aid. It does not deliver ablation energy, modify the ablation procedure, or replace standard phrenic nerve monitoring methods used by the physician. Device function, signal stability, procedural use, and any device deficiencies or adverse events are documented during the study.
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
- 19 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or females >18 and ≤ 85 years of age
- •Subject willing to sign informed consent
- •Subject is a candidate for pulmonary vein ablation for the treatment of atrial fibrillation ablation procedures therapy
排除标准
- •Subjects with pacemaker or defibrillator leads placed through the vena cava
- •Subjects with implantable vena cava filter
- •Subjects with a contraindication to contrast dye
- •Pregnant subjects
- •Subjects with inadequate venous access due to prior vein thrombosis or indwelling chronic ports or catheters
- •Subjects participating in another clinical trial that has not reached the follow-up time point to primary endpoint assessment
- •Subjects with known neuromuscular disease or other medical history (i.e trauma, surgery) that could have impacted diaphragmatic function
研究组 & 干预措施
Circle Safe System During Pulmonary Vein Ablation
Participant will undergo pulmonary vein ablation while the Circle Safe System stimulates the right phrenic nerve
干预措施: Circle Safe System Use During Pulmonary Vein Ablation (Device)
结局指标
主要结局
Freedom from device-related Major Adverse Events (MAEs) through hospital discharge. MAEs are defined as major thromboembolic events, vascular damage requiring surgical intervention, tamponade, perforation and ischemic stroke attributable to the device
时间窗: Through index discharge, an average of 24 hours
Proportion of subjects free from device-related Major Adverse Events (MAEs) through hospital discharge. MAEs are defined as major thromboembolic events, vascular damage requiring surgical intervention, tamponade, perforation, and ischemic stroke attributable to the Circle Safe System.
Primary Effectiveness Endpoint: Successful Recording and Display of Diaphragmatic Compound Motor Action Potential (CMAP) by the Circle Safe System
时间窗: Periprocedural
Ability of the Circle Safe System to record and display diaphragmatic compound motor action potential (CMAP) of patients undergoing pulmonary vein ablation procedures. Successful CMAP recordings are defined as: * The phrenic nerve can be captured consistently * A large, stable diaphragmatic CMAP baseline is recorded * Changes in amplitude can be tracked reliably throughout the ablation
次要结局
未报告次要终点