A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal Atrial Fibrillation - Post Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Kardium Inc.
- 入组人数
- 250
- 主要终点
- 12-month Treatment Success Rate
研究概览
简要总结
This study will evaluate the long-term safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal atrial fibrillation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of recurrent symptomatic paroxysmal atrial fibrillation
- •Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III
排除标准
- •Persistent or long-standing persistent atrial fibrillation (continuous atrial fibrillation that is sustained >12 months)
- •Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
- •History of thromboembolic events within the past six months
- •Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months
- •Any cardiac surgery within the previous six months
- •Prior left atrial ablation or surgical procedure
- •Presence of any pulmonary vein stents
- •Body mass index (BMI) >40 kg/m^2
- •Left ventricular ejection fraction (LVEF) <35%
- •Anterior-posterior left atrial (LA) diameter >55mm
结局指标
主要结局
12-month Treatment Success Rate
时间窗: 12 months
The rate of 12-month treatment success following ablation procedure using the Globe Pulsed Field System. Treatment success is defined as freedom from treatment failure, where treatment failure includes: * Documented recurrence of atrial fibrillation, atrial flutter, atrial tachycardia (AF/AFL/AT) as evidenced by episodes ≥ 30 seconds on Holter monitoring or equivalent during the effectiveness evaluation period, or by an episode documented on the entire recording of the 12-lead ECG (≥ 10 seconds) at the 12-month evaluation/visit. * Acute procedural failure * Direct current (DC) cardioversion for AF/AFL/AT during the effectiveness evaluation period * Redo ablation failure * Antiarrhythmic drugs (AADs) failure * Surgical treatment for AF/AFL/AT after the index procedure
Primary Safety Event Rate
时间窗: 7 days
Rate of subjects presenting with one or more primary safety events up to and including 7 days after the index ablation procedure. Primary safety events comprise the following device- or procedure-related serious adverse events: * Death * Cardiac tamponade/perforation * Heart block * Major vascular access complication * Major bleeding * Myocardial infarction (MI) * Pericarditis requiring intervention * Pulmonary edema * Stroke/cerebrovascular accident (CVA) * Thromboembolism * Transient ischemic attack (TIA) * Vagal nerve injury resulting in gastroparesis * Atrio-esophageal fistula * Diaphragmatic paralysis/phrenic nerve injury * Severe pulmonary vein (PV) stenosis
次要结局
未报告次要终点