ACTRN12613000083796招募中未知
In patients with severe Aortic Stenosis undergoing Transcatheter Aortic Valve Implantation (TAVI), what associated neurological injury exists as measured radiologically (magnetic resonance imaging), serological markers of neurological injury (s100B and GFAP) and clinically (neurological assessment, neurocognitive assessment, health-related quality of life scales).
Critical Care Research Group (CCRG)0 个研究点目标入组 80 人开始时间: 2013年1月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- o limit 至 o limit(—)
- 性别
- All
入选标准
- •All consenting patients undergoing transcatheter aortic valve implantation (TAVI) via the transfemoral, transaortic and transapical routes with the Edwards SAPIEN-XT valve under general anaesthetic.
排除标准
- •1. Lacks capacity to consent for him or herself.
- •2. Pre-existing neurological impairment measured as modified Rankin Score >=3.
- •3. Contraindication to MRI (including incompatible metallic prosthesis/foreign body, inability to lie flat, claustrophobia requiring sedation)
- •4. Non or poor English-speaking due to nature of cognitive testing and unknown validity in such populations
- •5. Previous aortic valve repair/replacement.
- •6. Coronary artery disease requiring revascularisation (including patients undergoing combined AVR and CABG).
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