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临床试验/NCT06120946
NCT06120946已完成不适用

The Influence of Cerebral Protection on Neurocognitive Outcomes Following Transcatheter Aortic Valve Implantation (TAVI)

Brighton and Sussex University Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年5月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Neurocognitive change

研究概览

简要总结

Severe aortic stenosis is a common heart condition affecting elderly patients. Degeneration of the aortic valve (oneway valve between the heart and the aorta) causes high resistence to blood flow, resulting in strain on the heart and the potential for heart failure and death. Treatment of aortic stenosis has traditionally been with open heart surgery. A new procedure called transcatheter aortic valve implantation (TAVI) allows new aortic valves to be implanted through the femoral arteries, resulting in equivalent outcomes to open surgery with a more rapid recovery. Some complications remain present however, including the risk of debris released during the valve implantation being carried by the blood stream into the brain. This may lead to strokes and a loss of mental capacity. Devices that filter the blood stream and capture this debris have now been developed but are of uncertain benefit. We plan to investigate the brain function of patients who have been randomly assigned to the TAVI procedure with and without the use of filters to see if there are any cognitive benefits to the use of this technology.

Patients who are enrolled in the BHF PROTECT-TAVI trial will be invited to partcipate in this trial. They will have already been randomly assigned to TAVI with or without cerebral filter use. We will perform a series of bedside clinical tests (lasting ~40 minutes) involving questionnaires, pen & paper and computer-based tasks. These will be performed both pre- and post-TAVI. There is no change to routine patient care. Data will be analysed with the assistance of trained neuropsychologists and will provide a valuable insight into the performance and role of the cerebral filter for TAVI patients in the future.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Randomised in the BHF PROTECT-TAVI trial (assessing stroke outcomes in TAVI with and without filter use).
  • Willing to provide informed consent for participation in this trial.

排除标准

  • Participant has been excluded from use of the filter device due to anatomical or clinical contra-indications.
  • Inadequate English skills.
  • Inability to complete assessment tasks due to visual or auditory impairment.

结局指标

主要结局

Neurocognitive change

时间窗: <3 days post-TAVI

Neurocognitive change by individual scores for each task performed

次要结局

  • Neurocognitive change(12-months post-TAVI)

研究者

发起方
Brighton and Sussex University Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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