Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant Pulsed Field Ablation Balloon for the Treatment of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CardioFocus
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary Effectiveness Endpoint - Acute Procedure Success
研究概览
简要总结
This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal (short-duration) AF who have not had a previous catheter ablation for AF will be considered for the study. Patients will be followed for one year after the initial ablation procedure.
详细描述
This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal AF who are undergoing first-time pulmonary vein isolation will be considered for the study. Patients will be followed for one year after the initial ablation procedure.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent symptomatic PAF with at least one documented episode
- •Failure or intolerance of at least one AAD
- •Age 18-75 years
- •Patient is indicated for an ablation procedure according to society guidelines or study site practice
- •Patient is willing and able to give informed consent/participate in baseline and follow-up assessments for the duration of the study
排除标准
- •overall good health as established by multiple criteria
研究组 & 干预措施
Treatment Arm
The treatment arm will undergo catheter ablation for symptomatic paroxysmal atrial fibrillation with the OptiShot Pulsed Field Ablation (PFA) Balloon System
干预措施: pulsed field ablation (Device)
结局指标
主要结局
Primary Effectiveness Endpoint - Acute Procedure Success
时间窗: During procedure
Pulmonary vein isolation at the end of the index procedure
Primary Safety Endpoint - Rate of Primary Serious Adverse Events
时间窗: 7 days (unless otherwise specified)
The rate of participants with at least 1 of the following Primary Serious Adverse Events occurring within 7 days unless otherwise specified: * AE fistula (assessed at \>=60 days) * Cardiac perforation, tamponade, or pericardial effusion * Complete heart block * Death * Major vascular access complications/bleeding requiring surgical intervention or blood transfusion * MI * Pericarditis * PNI resulting in persistent diaphragmatic paralysis (assessed at \<=60 days) * PV stenosis (assessed at \<=60 days) * Stroke/CVA * Thromboembolism * TIA * Vagal nerve injury/gastroparesis
次要结局
- Secondary Effectiveness Endpoint - Chronic Durability(90 days)
- Secondary Effectiveness Endpoint - 12-Month Freedom from Atrial Arrhythmia(12 months)