NL-OMON24028招募中不适用
Thoracoscopic surgical versus catheter ablation approaches for primary treatment of persistent atrial fibrillation
Amsterdam UMC0 个研究点目标入组 170 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
- 招募中
- 发起方
- 入组人数
- 170
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
入选标准
- •Age is between 18 and 80 years.
- •- Persistent AF as defined following the ESC 2016 Guidelines, evidenced by 1) ongoing AF on the ECG or 2) documentation of AF necessitating cardioversion.
- •- AF documented by ECG or Holter < 1 year ago.
- •- At least one class I or III anti-arrhythmic drug in standard dosage has failed or is not tolerated.
- •- Left atrial volume index = 45 ml/m2
- •- Legally competent and willing to sign the informed consent.
- •- Willing and able to adhere to the follow-up visit protocol.
- •- Life expectancy of at least 2 years.
排除标准
- •- Prior intervention (catheter ablation or minimally-invasive thoracoscopic ablation) for AF.
- •- AF is secondary to electrolyte imbalance, thyroid disease or other reversible or non-cardiovascular causes.
- •- Documentation of CTI dependent atrial flutter
- •- Valvular AF
- •- Paroxysmal AF
- •- Long standing Persistent AF, defined as AF continuously present for longer than 1 year.
- •- Body mass index >35kg/m2
- •- NYHA class IV heart failure symptoms or left ventricular ejection fraction <35%.
- •- NYHA class III heart failure symptoms, unless caused or aggravated by AF.
- •- Myocardial infarction within the preceding 2 months.
- •- Active infection or sepsis (as evidenced by increased white blood cell count, elevated CRP level or fever >38,5 °C).
- •- Known and documented carotid stenosis > 80%
- •- Planned cardiac surgery for other purposes than AF.
- •- Pregnancy or child bearing potential without adequate anticonception.
- •- Requirement of anti-arrhythmic drugs for ventricular arrhythmias.
- •- Presence of intracardiac mass or thrombus (discovery of any thrombus or intracardiac mass after signing of the informed consent will result in withdrawal of the subject from the study)
- •- Co-morbid condition that possesses undue risk of general anesthesia or port access cardiac surgery (in the opinion of the operator).
- •- History of previous radiation therapy on the thorax
- •- Circumstances that prevent follow-up
- •- No vascular access for catheterization.
- •- History of previous thoracotomy.
- •- Factors precluding transseptal puncture for catheterization. Sample size
研究者
相似试验
招募中
不适用
Thoracoscopic surgical versus catheter ablation approaches for primary treatment of persistent atrial fibrillatioAtrial fibrillationNL-OMON48892Academisch Medisch Centrum120
撤回
不适用
Catheter ablation versus video assisted thoracoscopic surgery for the treatment of (longstanding) persistent atrial fibrillatio10007521Atrial fibrillationNL-OMON41871niversitair Medisch Centrum Utrecht60
尚未招募
不适用
The CAVIAR-trialPersistent and longstanding persistent atrial fibrillationNL-OMON20520niversity Medical Center Utrecht (UMCU)60
已完成
不适用
Catheter versus thoracoscopic surgical ablation in long standing persistent atrial fibrillatioArrhythmiaISRCTN18250790Royal Brompton & Harefield NHS trust120
尚未招募
Unknown
Endocardial catheter ablation versus thoracoscopic ablation in de novo persistent atrial fibrillation patients with enlarged left atrium : A Randomized Controlled TrialDiseases of the circulatory systemKCT0009360Samsung Medical Center194