跳至主要内容
临床试验/NL-OMON50190
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

发起方
Medisch Universitair Ziekenhuis Maastricht

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