The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Proportion of subjects who are free from device/procedure related Major Adverse Events
研究概览
简要总结
The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)
详细描述
This clinical study is designed to evaluate the safety and performance of the PFA System in the ablation treatment of atrial fibrillation (AF). Data will be used to support regulatory submissions.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the ages of 18 to 80 years at time of consent
- •Clinically indicated and scheduled for a de novo catheter ablation of AF
- •Willing and able to provide written informed consent to participate in the study and agree to comply with all follow-up visits and evaluations for the duration of the study.
排除标准
- •In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications, atrial thrombus, renal failure, or sepsis.
- •Continuous episodes of AF duration lasting longer than 12-months
- •Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause.
- •Previous history of left atrial ablation (including surgical treatment) for AF/AT/AFL.
- •Structural heart disease or cardiac history as described below:
- •Left ventricular ejection fraction (LVEF) < 35%
- •Left atrial size > 60 mm
- •Evidence of heart failure (NYHA Class III or IV)
- •Unstable angina or ongoing myocardial ischemia
- •Recent myocardial infarction
- •Severe uncontrolled systemic hypertension
- •Moderate or severe valvular heart disease (stenosis or regurgitation).
- •Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder.
- •l. Presence of a left atrial appendage occlusion device. j. Previous PV stenting or evidence of PV stenosis.
- •Body Mass Index (BMI) > 42 kg/m2
- •History of blood clotting or bleeding disease.
- •ANY prior history of documented cerebral infarct (stroke), or systemic embolism (excluding post-operative deep vein thrombosis (DVT)).
- •History of obstructive sleep apnea not currently being treated.
- •Pregnant or lactating (current or anticipated during study follow-up).
- •Any other condition that, in the judgment of the Investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center).
结局指标
主要结局
Proportion of subjects who are free from device/procedure related Major Adverse Events
时间窗: 6 months
The Primary Endpoint for Safety is an analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the ablation procedure through 6-months.
Acute documentation of pulmonary vein isolation (PVI) for each treated pulmonary vein (PV)
时间窗: 20 minutes post ablation
The Primary Endpoint for efficacy is the number of subjects where ablation of each accessible pulmonary vein (PV) resulted in confirmation of electrical isolation of the pulmonary vein (PVI) 20 minutes following the last index PFA/RF application with the investigational device
次要结局
- Analysis of all identified SAEs, SADEs, and UADEs(12 months)
- Subjects with freedom from an atrial arrhythmia(12 months)