Real World Data Collection in Chinese Population Treated With the FARAPULSE™ Pulsed Field Ablation System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Failure-free rate
研究概览
简要总结
To obtain real world data on the use of, and provide continued evidence on safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) system when used per hospitals' standard of care in Chinese population.
详细描述
The study is an observational, prospective, non-randomized, single-arm, multi-center post-market study.
All subjects signing the informed consent form, will be included in the study. All subjects treated with the FARAPULSE™ PFA system will be followed for three years.
Subjects will undergo the index procedure per hospitals' standard of care after enrollment, and followed at pre-discharge, 3 Month, 6 Month (Phone call only), 12 Month (in-clinic visit mandatory), 24 Month (2 Year) and 36 Month (3 Year).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Subjects intended to be treated with the FARAPULSE™ Pulsed Field Ablation system for cardiac tissue ablation, per physician's medical judgement, and as per hospitals' standard of care
- •Subjects who are willing and capable of providing informed consent
- •Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center
- •Subjects whose age is 18 years or above.
排除标准
- •Subjects with a current interatrial baffle or patch
- •Subjects with a known or suspected atrial myxoma
- •Subjects with a myocardial infarction within 14 days prior to enrollment
- •Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA)
- •Subjects who do not tolerate anticoagulation therapy
- •Subjects with an active systemic infection *
- •Subjects with a presence of atrial known thrombus *
- •Subjects with a known inability to obtain vascular access
- •Subjects who are pregnant or planning to be pregnant
- •Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
- •Subjects with any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
- •Subjects with a contraindication to an invasive electrophysiology procedure where insertion or manipulation of a catheter in the cardiac chambers is deemed unsafe per physician's medical judgement, such as, but not limited to, a recent previous cardiac surgery (e.g., ventriculotomy or atriotomy, CABG, PTCA/PCI/coronary stent procedure), recent previous unstable angina and/or in patients with congenital heart disease where the underlying abnormality increases the risk of the ablation (e.g., severe rotational anomalies of the heart or great vessels)
- •Subjects with a life expectancy of ≤ 1 year per investigator's opinion
- •Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility.
结局指标
主要结局
Failure-free rate
时间窗: 12 Months
Failure-free rate at 12 Month post index procedure.
Device-or procedure-related SAEs:
时间窗: 7 days and 12 months
Composite of the following device- or procedure-related SAEs:
Procedure- and device related adverse events
时间窗: 12 Months and 2 years and 3 years
All FARAPULSE™ PFA procedure- and device related adverse events at 12 Month, 2 Year and 3 Year follow-up.
次要结局
未报告次要终点