NL-OMON53941招募中不适用
Real world Data collection in subjects treated with the FARAPULSE* Pulsed Field Ablation system - FARADISE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. 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
- •2. Subjects who are willing and capable of providing informed consent
- •3. Subjects who are willing and capable of participating in all testing
- •associated with this clinical study at an approved clinical investigational
- •4. Subjects whose age is 18 years or above, or who are of legal age to give
- •informed consent specific to state and national law
排除标准
- •1. Subjects with a current interatrial baffle or patch
- •2. Subjects with a known or suspected atrial myxoma
- •3. Subjects with a myocardial infarction within 14 days prior to enrollment
- •4. Subjects with a recent (within 30 days prior to enrollment) Cerebral
- •Vascular Accident (CVA)
- •5. Subjects who do not tolerate anticoagulation therapy
- •6. Subjects with an active systemic infection
- •7. Subjects with a presence of atrial known thrombus
- •8. Subjects with a known inability to obtain vascular access
- •9. Subjects who are pregnant or planning to be pregnant
- •10. Subjects with atrial fibrillation that is secondary to electrolyte
- •imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
- •11. Subjects with any prosthetic heart valve, ring or repair including balloon
- •aortic valvuloplasty
- •12. 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/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)
- •13. Subjects with a life expectancy of <= 1 year per investigator*s opinion
- •14. 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.
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