NCT05164107招募中不适用
PULSE-EU - A Prospective, Non-Randomized Clinical Pilot Study to Assess Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Kardium Inc.
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Rate of subjects presenting with primary safety events which are device- or procedure-related
研究概览
简要总结
The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Subjects planned for an AF catheter ablation procedure, with a documented history of AF.
- •Diagnosis must be confirmed within 12 months before enrollment.
- •(Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation
- •Subjects between 18 and 75 years of age, inclusive
排除标准
- •Patients who have contraindications to open heart surgery
- •Patients from an Intensive Care Unit
- •Patients with active systemic infection (sepsis)
- •Patients who have had previous ablation in the left or right atrium
- •Patients who are post-heart transplant or who are awaiting cardiac transplantation or other cardiac surgery
- •Patients with cardiac implants that may interfere with device delivery or positioning (e.g. atrial septal defect closure device, left atrial appendage occluder)
- •Patients with mitral valve prolapse or other heart valve abnormalities excepting mild to moderate mitral regurgitation
- •Patients with New York Heart Association Class III or IV heart failure
- •History of a documented thromboembolic event, including stroke or transient ischemic attack (TIA)
- •Bleeding disorder history
- •Patients with a known sensitivity to anesthesia or neuromuscular block agent
- •Currently undergoing long-term treatment with steroids, not including intermittent use of inhaled steroids for respiratory disease
- •Myocardial infarction within the last three months
- •Atrioventricular (AV) block II° or III°
- •Left ventricular ejection fraction (LVEF) of less than 35%
- •Unstable angina
研究组 & 干预措施
Globe Mapping and Pulsed Field Ablation System
Experimental
干预措施: Globe Mapping and Pulsed Field Ablation System (Globe PF System) (Device)
结局指标
主要结局
Rate of subjects presenting with primary safety events which are device- or procedure-related
时间窗: up to 3-month visit
次要结局
未报告次要终点
研究者
研究点 (1)
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