NL-OMON50951招募中不适用
Anxiety Reduction in TAVI using Virtual Reality Trial - ART-VR
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
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
- •o Age * 18 years
- •o Symptomatic severe aortic stenosis
- •o Indication for transfemoral TAVI under local anaesthesia per local heart team
- •o Patient is able to understand and sign written informed consent
- •o Patient speaks Dutch, German or English
排除标准
- •o Need for emergent TAVI
- •o Need for planned concomitant cardiac intervention during index procedure
- •o History of TAVI under local anesthesia/conscious sedation
- •o Chronic use of benzodiapines, opioids, pregabalin or antidepressants
- •o History of opioid use (within 8-30 days prior to randomization)
- •o Claustrophobia
- •o Any psychiatric illness diagnosed by a psychiatrist or psychologist
- •o Blindness or severe visual impairment despite visual aid (glasses, contact
- •o Extensive cognitive impairment (MMSE <21 or as diagnosed by geriatrician)
研究者
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