A Real-world Study of the FARAPULSE Pulsed Field Ablation System in A Chinese Population With Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants With Acute Procedural Success
研究概览
简要总结
The real world study is a retrospective and/or prospective, single-center, single-arm observational study to observe the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System for treatment of recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF) in a Chinese population.
详细描述
The primary effectiveness endpoint is the acute procedural success, defined as the proportion of subjects that achieve electrical isolation of all PVs using FARAPULSE Pulsed Field Ablation system only.
The primary safety endpoint is defined as the occurrence of the acute serious procedure-related and /or device-related adverse events at 7 days post index procedure.
Primary endpoints analysis is planned to be conducted after all enrolled subjects have completed data collection at 1-month follow-up visit. All the subjects underwent study device treatment will be followed up to 12 months after the procedure, and the secondary and other endpoints will be analyzed then.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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 who are ≥ 18 and ≤ 75 years of age on the day of enrollment;
- •Subjects whose preoperative diagnosis is PAF confirmed by the clinician;
- •De novo ablation procedure for PAF with Class I or IIa recommendations* according to 2018 Chinese expert consensus on atrial fibrillation therapy;
- •Subjects who are able and willing to provide the defined observational data and/or participate in baseline and follow-up evaluations for the full study;
- •Subjects who are willing and capable of providing informed consent.
排除标准
- •Subjects who, in the judgment of the investigator, have a life expectancy of less than one year before the procedure;
- •Women of childbearing potential who are, or plan to become, pregnant during the time of the study;
- •Subjects with any known contraindication to AF ablation with FARAPULSE Pulsed Field Ablation system, anticoagulation therapy, or contrast media in the judgment of the investigator or subjects unwillingness to use systemic anticoagulation
- •Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study.
结局指标
主要结局
Number of Participants With Acute Procedural Success
时间窗: Day 0
The primary effectiveness endpoint is the acute procedural success, defined as the proportion of subjects that achieve electrical isolation of all PVs using FARAPULSE Pulsed Field Ablation system only.
Number of Participants With SAE Related to the Procedure or Device at 7 Days Post Index Procedure
时间窗: 7 Days
The primary safety endpoint is defined as the occurrence of the acute serious procedure-related and /or device-related adverse events at 7 days post index procedure.
次要结局
未报告次要终点