PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 580
- 试验地点
- 35
- 主要终点
- Safety- Freedom from Device/Procedure Related Adverse Events
研究概览
简要总结
PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.
详细描述
PulseSelect is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months. Study visits will occur at 3, 6, 12, 24, and 36 months post-ablation, including required 24-hour Holter monitoring at 6, 12, 24, and 36 month visits. The PulseSelect™ PFA System used in this study is market approved and the ablation procedure will be performed according to hospital standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 AF or persistent AF
- •Refractory to at least one Class I or III antiarrhythmic drug (i.e., not effective, not tolerated, or not desired)
- •Patient is ≥ 18 years of age
- •Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System
- •Willing and able to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements
排除标准
- •Long-standing persistent AF (continuous AF sustained >12 months)
- •Prior left atrial catheter or surgical ablation
- •Patient with life expectancy < 36 months
- •Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
- •Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager
研究组 & 干预措施
Paroxysmal
Ablation using the PulseSelect™ PFA system
干预措施: PulseSelect™ PFA system (Device)
Persistent
Ablation using the PulseSelect™ PFA system
干预措施: PulseSelect™ PFA system (Device)
结局指标
主要结局
Safety- Freedom from Device/Procedure Related Adverse Events
时间窗: 6 months post-ablation]
Estimate the rate of major procedural complications for catheter ablation using PulseSelect™ PFA system.
Efficacy-Freedom from Atrial Fibrillation
时间窗: 36-months after the index ablation procedure
Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system.
次要结局
未报告次要终点