British Heart Foundation Randomised Trial of Routine Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation

niversity of Oxford0 个研究点目标入组 7,730 人开始时间: 2020年6月23日最近更新: 2024年1月15日

适应症

试验速览

暂无简介。

•Current inclusion criteria as of 04/11/2021:
•1. Participant is willing and able to give informed consent for participation in the trial
•2. Aged 18 years or above
•3. Considered to be candidates for TAVI by the clinical team (via any access route where CEP may be used)
•4. Participant is suitable for treatment with the cerebral embolic protection device in the opinion of the treating physician
•Previous inclusion criteria:
•1. Willing and able to give informed consent for participation in the trial.
•2. Aged 18 years or above
•3. Diagnosed with aortic stenosis (including bioprosthetic valve dysfunction)
•4. Planned transfemoral TAVI

•Current exclusion criteria as of 04/11/2021:
•No specific exclusion criteria.
•Participants involved in observational studies will be eligible for this study. As this is an all-comer design, current or previous participation in other ongoing randomised trials will not be disqualifying for recruitment to this study unless treatment is expected to impact the effect of using a CEP device on stroke.
•Previous exclusion criteria:
•1. Anatomically unsuitable for treatment with the cerebral embolic protection device in the opinion of the treating physician
•2. Clinical contra-indications to the use of the CEP device in the opinion of the treating physician

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