The VAD Outcome study

• Research type

  Research Study

• Full title

  A cross-sectional evaluation of neurodevelopmental and neurocognitive outcomes in children and young people who had a ventricular assist device as a bridge to heart transplantation

• IRAS ID

  360492

• Contact name

  Jo Wray

• Contact email

  joanne.wray@ucl.ac.uk

• Sponsor organisation

  University College London

• Clinicaltrials.gov Identifier

  Z6364106/2025/12/17 , UCL Data Protection Registration Number

• Duration of Study in the UK

  1 years, 4 months, 31 days

• Research summary

  Ventricular assist device (VAD) therapy, which involves insertion of a mechanical pump to take over the function of the heart, is now a mainstay of treatment for children with severe heart failure and provides a therapeutic option whilst decisions are made as to the likelihood of recovery or need for transplantation. However, risks of medical complications such as stroke and infection are significant and VAD therapy places considerable demands on both children and their families. We know that children who have been on VAD prior to transplant are at greater risk of poor psychosocial outcomes and are at greater risk of neurocognitive difficulties post-transplant but we lack detailed knowledge about which outcomes should be routinely measured.

  The aims of our study are to:
  1. Explore the neurocognitive and neurodevelopmental outcomes for children who have been on VAD and received a heart transplant and
  2. Identify efficient and valid follow-up pathways to improve holistic patient outcomes

  We will invite all children (approximately 70) currently under Great Ormond Street Hospital (GOSH) who have been on a VAD prior to receiving a heart transplant at least 12 months previously to participate. Children will be invited to take part in face-to-face developmental/cognitive assessments and screening questionnaires depending on the age of the child and parents will be invited to complete questionnaires about their own and their child's psychological functioning. With parental consent, we will also approach the child's school (if applicable) to complete questionnaires about the child's academic attainments and behaviour at school.

  Through better understanding of psychosocial outcomes in this cohort of patients we aim to improve the patient care delivered by GOSH through the development of training and resources for families and clinicians to help improve long-term outcomes.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  26/SC/0112

• Date of REC Opinion

  21 Apr 2026

• REC opinion

  Further Information Favourable Opinion