NL-OMON47579暂停3 期
Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach for Treatment of Subjects with Persistent or Long Standing Persistent Atrial Fibrillation with Radiofrequency Ablation - DEEP Pivotal Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue)
- •Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation
- •refractory to a minimum of one Class I or Class III AADs.
排除标准
- •Patient has undergone prior cardiothoracic surgery (lungs or mediastinum).
- •Patient has NYHA Class IV heart failure.
- •Patient has an ejection fraction < 30% (based on baseline transthoracic
- •echocardiography or equivalent diagnostic test).
- •Patient has evidence of underlying Coronary Artery Disease requiring
- •intervention (either surgical, i.e. CABG, or catheter).
研究者
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