EUCTR2021-006614-37-SE进行中（未招募）1 期
First-line cryoablation for early treatment of Persistent Atrial Fibrillation – a randomized study comparing early trigger isolation using the Cryoballoon versus antiarrhythmic medication. - CryoStopPersAF
Region Örebro0 个研究点目标入组 220 人开始时间: 2022年3月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Non-longstanding persistent symptomatic AF with at least 2 episodes within last 24 months (both shorter than 12 months in duration), the latest episode within the previous 6 months and, one should be documented on a 12 lead ECG or Holter monitor.
- •a.Classical persistent AF as defined by ESC guidelines14,
- •b.Persistent AF which has progressed from paroxysmal AF (patients who have been cardioverted within 7 days of onset provided a history of spontaneous conversion of episodes to sinus rhythm is lacking in near time)
- •2.Age 18 – 75 years,
- •3.Candidate for rhythm control therapy; AF ablation or AAD based on symptomatic AF
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Regular daily use of antiarrhythmic drugs of class I or III at adequate therapeutic dosages (pill-in-the-pocket permitted, beta-blockers permitted).
- •2.Previous AF ablation or surgery.
- •3.Severe heart failure (NYHA III-IV).
- •4.Reduced left ventricular ejection fraction (LVEF <30%).
- •5.Severely enlarged LA with left atrial volume indexed to body surface area (LAVI, ml/m2) > 48.
- •6.Significant valvular disease requiring treatment or valve protesis.
- •7.Severe COPD stage III or chronic kidney disease (eGFR< 30 umol/l)).
- •8.Planned cardiac intervention within the next 12 months or cardiac surgery last 6 months.
- •9.Myocardial infarction, revascularisation previous 6 months.
- •10.Stroke or TIA within previous 6 months.
- •11.Tachycardiomyopathy.
- •12.Dependent on VVI pacing.
- •13.Conventional contraindications for AF ablation including AF due to reversible causes and contraindications for both class IC and class III antiarrhythmic drugs.
- •14.Expected survival less than 3 years, alcohol or drug abuse.
- •15.Participation in another trial or absence of consent.
研究者
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