NL-OMON50190已完成不适用
Hybrid Thoracoscopic Surgical and Transvenous Catheter Ablation versus Repeated Transvenous Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation - HARTCAP-AF
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- •The patient is must be a candidate for an interventional treatment strategy and
- •* Known with a history of symptomatic persistent AF (continuous AF lasting > 7
- •days) or longstanding persistent AF (continuous AF lasting > 1 year),
- •* Refractory to or intolerant of at least one antiarrhythmic drug class I or
- •* At least 18 years of age,
- •* Mentally able and willing to give informed consent.
排除标准
- •* Referred specifically for a hybrid ablation,
- •* Previous ablation procedure,
- •* Longstanding persistent AF > 3 years,
- •* Paroxysmal atrial fibrillation,
- •* AF secondary to electrolyte imbalance, thyroid disease, or other reversible
- •or non-cardiovascular cause,
- •* Presence of left atrial appendage (LAA) thrombus,
- •* Left atrial size * 60mm (PLAX-view on TEE),
- •* Left ventricular ejection fraction < 40%,
- •* In need for other cardiac surgery then AF treatment within 12 months,
- •* Intolerance to heparin and warfarin,
- •* Unable to undergo TEE,
- •* Sick-sinus-syndrome
- •* Mitral valve insufficiency > Iº
- •* Carotid stenosis > 80%,
- •* Active infection or sepsis,
- •* Pleural adhesions,
- •* Elevated hemi diaphragm
- •* Significant pulmonary dysfunction as assessed by preoperative lung testing,
- •* Chronic obstructive pulmonary disease with a FEV1 or VC < 50% predicted,
- •* History of cerebrovascular accident (CVA) or transient ischemic attack (TIA),
- •* History of blood clotting abnormalities,
- •* History of thoracic radiation,
- •* History of pericarditis,
- •* History of cardiac tamponade,
- •* History of thoracotomy or cardiac surgery,
- •* Body-mass-index > 40,
- •* Pregnancy,
- •* Life expectancy less than 12 months,
- •* Participation in any other clinical study involving an investigational drug
研究者
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