NL-OMON52465已完成不适用
A randomized, controlled study to evaluate the reliability of the Ablacon Electrographic FLOW (EGF) algorithm technology (Ablamap® Software) to identify AF sources and guide ablation therapy in patients with persistent atrial fibrillation - FLOW-AF
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
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. Suitable candidate for intra-cardiac mapping and ablation of arrhythmias
- •2. Above eighteen (18) years of age or of legal age to give informed consent
- •specific to state and national law
- •3. Subjects with a history of documented symptomatic, persistent or
- •longstanding persistent atrial fibrillation < 36 months
- •4. Subject agrees to comply with study procedures and be available
- •(geographically stable) for follow-up visits for at least 12 months
- •5. Treatment of atrial fibrillation with ablation therapy presenting with
- •recurrent symptoms of AF
排除标准
- •1. LA diameter > 5.5 cm.
- •2. Left ventricular ejection fraction (LVEF) < 35%
- •3. Presence of intramural thrombus, tumor or abnormality that precludes
- •vascular access, catheter introduction or manipulation
- •4. Coagulopathy, bleeding diathesis or suspected procoagulant state
- •5. Known allergies or intolerance to anticoagulant and antiplatelet therapies
- •to be used in conjunction with the study or contrast sensitivity that cannot be
- •adequately pre-treated prior to the ablation procedure
- •6. Positive pregnancy test results for female patients of childbearing
- •potential or breast feeding
- •7. Acute or chronic medical condition that in the judgment of the investigator
- •would increase risk to the patient or deem the patient inappropriate to
- •participate in the study
- •8. Mitral valve stenosis and/ or severe mitral regurgitation
- •9. Valvular atrial fibrillation
- •10. Prosthetic valves
- •11. NYHA Class IV
- •12. History of MI within 3 months prior to procedure
- •13. Atrial septal defect (ASD) or Left Atrial Appendage (LAA) closure device.
- •14. Atrial fibrillation from a reversible cause (e.g., surgery,
- •hyperthyroidism, sarcoidosis or pericarditis)
- •15. Life expectancy < 12 months based on medical history or the medical
- •judgement of the investigator
- •16. Presence of any transvenous pacing, ICD, or CRT leads
研究者
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