RESTORE-TAVI Pilot

  • Research type

    Research Study

  • Full title

    A pilot study assessing the feasibility and effectiveness of a perioperative multi-component intervention in patients with acute decompensated aortic stenosis undergoing urgent Transcatheter Aortic Valve Intervention

  • IRAS ID

    330818

  • Contact name

    Michael Mullen

  • Contact email

    mmullen@nhs.net

  • Sponsor organisation

    Barts Health NHS Trust

  • Clinicaltrials.gov Identifier

    NCT06121921

  • Clinicaltrials.gov Identifier

    160297, EDGE

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    Patients admitted to hospital with acute decompensated aortic stenosis (ADAS) are increasingly undergoing urgent transcatheter aortic valve implantation (TAVI) during their index presentation. By definition, these patients are of high surgical risk and are commonly frail. As such, they are at risk of hospital-acquired disability, delirium and malnutrition that can limit functional recovery upon hospital discharge. This pilot study will investigate the feasibility of delivering a perioperative multicomponent intervention comprising physical rehabilitation, delirium prevention strategies and nutritional supplementation (if indicated) and whether this reduces adverse hospital events (e.g. hospital-acquired disability, postoperative delirium) and functional status compared to standard inpatient care.

  • REC name

    London - London Bridge Research Ethics Committee

  • REC reference

    24/LO/0345

  • Date of REC Opinion

    3 May 2024

  • REC opinion

    Further Information Favourable Opinion