ISRCTN18250790已完成未知
CAtheter versus thoracoscopic Surgical Ablation in long standing persistent atrial fibrillation: a multicentre randomised controlled trial
Royal Brompton & Harefield NHS trust0 个研究点目标入组 120 人开始时间: 2015年4月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29458408 protocol 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32860414/ results (added 02/09/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34726873/ (added 19/05/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age = 18 years
- •2. LSPAF (> 12 months’ duration)
- •3. EHRA > 2
- •4. Left ventricular ejection fraction = 40%
- •5. Suitable for either ablation procedure (added 05/05/2016)
排除标准
- •Exclusion criteria as of 05/05/2016:
- •1. Valvular heart disease with severity greater than mild
- •2. Contraindication to anticoagulation
- •3. Thrombus in the left atrium despite anticoagulation in therapeutic range
- •4. Cerebrovascular accident within the previous 6 months
- •5. Previous thoracic or cardiac surgery (including surgical interventions for AF)
- •6. Prior left atrial catheter ablation for AF
- •7. Unable to provide informed written consent
- •8. Active malignancy, another severe concomitant condition or presence of implanted intracardiac devices that would preclude patient undergoing study specific procedures
- •9. Pregnant or breast-feeding, or women of childbearing age not using a reliable contraceptive method
- •Previous exclusion criteria:
- •1. Significant valvular heart disease
- •2. Contraindication to anticoagulation
- •3. Thrombus in the left atrium despite anticoagulation
- •4. Cerebrovascular accident within the previous 6 months
- •5. Significant previous thoracic or cardiac surgery (including surgical interventions for AF)
- •6. Prior left atrial catheter ablation for AF
- •7. Unable to provide informed written consent
- •8. Active malignancy or another severe concomitant condition that would preclude patient undergoing study specific procedures
- •9. Pregnant or breastfeeding, or women of childbearing age not using a reliable contraceptive method
研究者
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