DRKS00010840尚未招募4 期
A prospective, randomized, controlled, non-inferiority trial comparing RF- energy and cryoenergy in pulmonary vein isolation in patients with persistent atrial fibrillation - FreezeAF II
Medizinische Klinik IVStädtisches Klinikum Karlsruhe0 个研究点目标入组 340 人开始时间: 2017年4月26日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 340
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Documented PersAF: at least 1 episode of PersAF > 7 days and less than 2 years (at least one episode documented)
- •2. Age 18-80 years
- •3. Documented inefficacy of at least 1 AAD including beta- blockers
- •4. Willigness to have rhythm monitoring performed by either internal loop recorder readings or 7 to 14 day external Event recorder reading
排除标准
- •1.LA size > 55 mm
- •2. LA thrombus
- •3. Previous LA ablation/surgery
- •4. Unstable angina
- •5. Myocardial infarction within three months
- •6. Cardiac surgery or PTCA within three months
- •7. Mitral prosthesis
- •8. EF <40%
- •9. Heart failure NYHA III-IV
- •10. Hypertrophic cardiomyopathy
- •11. Severe or moderate mitral regurgitation
- •12. Any condition contraindicating chronic anticoagulation
- •13. Stroke or TIA within six months
- •14. Thrombocytosis, thrombocytopenia
- •15. Pregnancy
- •16. Uncontrolled hyperthyroidism
- •17. Life expectancy <1year
研究者
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