NL-OMON52211招募中4 期
Comparing effectiveness and safety of Left Atrial Appendage Occlusion for non-valvular Atrial Fibrillation patients at high stroke risk unable to use oral anticoagulation therapy - COMPARE-LAAO
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 609
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 99（—）
入选标准
- •1. Documented non-valvular AF (paroxysmal or non-paroxysmal) and
- •2. CHA2DS2-VASc score of 2 or more and
- •3. unsuitable for long-term use of oral anticoagulation as determined by the
- •referring physician team as well as the multidisciplinary team in the study
- •hospital and
- •4. suitable for dual ATP for at least 3 mo and single APT from 3 until at most
- •5. At least 18 years of age, and willing and able to provide informed consent
- •and adhere to study rules and regulations and follow-up
排除标准
- •1. any invasive cardiac procedure within 30 days prior to randomization and 90
- •days after LAAO that would interfere with the study follow-up and medication
- •2. unsuitable LAA anatomy for closure or thrombus in the LAA at the time of
- •3. contraindications or unfavourable conditions to perform cardiac
- •catheterization or TEE
- •4. atrial septal malformations, atrial septal defect or a high-risk patient
- •foramen ovale that may cause thrombo-embolic events
- •5. atrial septal defect repair or closure device or a patent foramen ovale
- •repair or any other anatomical condition as this may preclude an LAAO procedure
- •6. LVEF<31% and/or heart failure NYHA 3-4
- •7. Mitral valve regurgitation grade 3 or more
- •8. Mitral stenosis as this makes AF by definition valvular in nature
- •9. Aortic valve stenosis (AVA<1.0 cm2 or Pmax>50 mmHg) or regurgitation grade 3
- •10. Planned cardiac surgery for any reason within 3 months
- •11. Stroke within the 3 months prior to inclusion
- •12. Major bleeding (BARC criteria>type 2) within 1 month prior to inclusion or
- •longer if it has not been resolved yet
- •13. Compelling medical reason to use VKA or NOAC (e.g. mechanical heart valve,
- •pulmonary embolism, ventricular aneurysm)
- •14. Major contraindications for using aspirin or clopidogrel
- •15. (planned) pregnancy
- •16. Participation in any other clinical trial that interferes with the current
- •17. Life expectancy of less than 1 year
研究者
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