NL-OMON53275尚未招募不适用
Effect of a bigger cryoballoon on the total antral lesion size: Evaluation of POLARx FIT - BETTER-FIT study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
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. History of symptomatic paroxysmal AF
- •2. Subjects who are indicated for a PVI according to the 2020 ESC guidelines
- •for the diagnosis and management of AF
- •3. Subjects who are willing and capable of providing informed consent
- •4. Subjects who are willing and capable of participating in all testing
- •associated with this clinical investigation
- •5. Subjects whose age is 18 years or above
排除标准
- •1. Any known contraindication to an AF ablation or anticoagulation
- •2. History of previous left atrial ablation or surgical treatment of AF, atrial
- •flutter, or atrial tachycardia
- •3. AF secondary to electrolyte imbalance, thyroid disease, or any other
- •reversible or noncardiac cause
- •4. Significant structural heart disease
- •5. History of blood clotting or bleeding disease
- •6. Stroke or transient ischemic attack <3 months prior to enrollment
- •7. Active systemic infection
- •8. Common ostium PV >24 mm defined by CT-scan
- •9. Pregnant, lactating, or women of childbearing potential who are, or plan to
- •become, pregnant during the time of the study
- •10. Subjects who are currently enrolled in another investigational study or
- •registry that would directly interfere with the current study
研究者
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