CTIS2023-505962-28-00招募中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 Oerebro Laen0 个研究点目标入组 270 人开始时间: 2023年6月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 270
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 65+（—）
- 性别
- All
入选标准
- •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 guidelines, 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), Age 18 – 75 years, Candidate for rhythm control therapy; AF ablation or AAD based on symptomatic AF. As an example, BMI >35 would not according to clinical praxis be a candidate for AF ablation and thereby not suitable for participation in the study.
排除标准
- •Regular daily use of antiarrhythmic drugs of class I or III at adequate therapeutic dosages (pill-in-the-pocket permitted, beta- blockers permitted)., Myocardial infarction, revascularisation previous 6 months., Stroke or TIA within previous 6 months., Tachycardiomyopathy., Dependent on VVI pacing., Conventional contraindications for AF ablation including AF due to reversible causes and contraindications for both class IC and class III antiarrhythmic drugs., Expected survival less than 3 years, alcohol or drug abuse., Participation in another trial or absence of consent., Previous AF ablation or surgery., Severe heart failure (NYHA III-IV)., Reduced left ventricular ejection fraction (LVEF =40 % during sinus rhythm)., Hypertrophic cardiomyopathy (septal or posterior wall thickness >1.5 cm), Severely enlarged LA with left atrial volume indexed to body surface area (LAVI, ml/m2) > 48., Significant valvular disease requiring treatment or valve protesis., Severe COPD stage III or chronic kidney disease (eGFR< 30 umol/l)., Planned cardiac intervention within the next 12 months or cardiac surgery last 6 months.
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