IMPLIED TAVI

• Research type

  Research Study

• Full title

  Impact of large effective orifice area in patients undergoing transcatheter aortic valve implantation

• IRAS ID

  358535

• Contact name

  Mohammad ALKHALIL

• Contact email

  mohammad.alkhalil@nhs.net

• Sponsor organisation

  Newcastle NHS Foundation Trust

• Duration of Study in the UK

  1 years, 8 months, 3 days

• Research summary

  Patients who undergo keyhole procedure to insert a new heart valve (trans-catheter aortic valve implantation or TAVI) are subjected to different valve types. The performance of any keyhole valve may vary in patients with a relatively small valve (or small anatomy). Recent data suggest that self-expanding valves may be better than valves which are mounted on a balloon (balloon expandable valves). Self-expanding valve means that they automatically expand once released from their delivery system.
  This study is designed to assess if there are any differences in the performance of two established self-expanding keyhole valves. Patients who are identified to have small valves will be randomised, after obtaining consent form, to receive either allegra or evolut self-expanding valves. The leaflets of allegra are made from bovine (from a cow) heart tissue, while evolut is made of porcine (from a pig) heart tissue. The opening area (or effective orifice area) of the allegra is larger than evolut but the frame has different strengths between the two valves. Therefore, there may be a difference in the performance between the two keyhole valves. This will be assessed using blood samples before and after inserting the new keyhole valve. These blood samples would allow calculating the ability of the heart in pumping blood across the new keyhole valve. The total amount of blood will be around 45-50 ml (or three large tablespoons). Additionally, participants will undergo echocardiogram (heart scan) whilst they are pedalling on a stationary bike. This will allow better assessment of patients’ symptoms and valve performance during exercise.

• REC name

  South East Scotland REC 01

• REC reference

  25/SS/0066

• Date of REC Opinion

  14 Oct 2025

• REC opinion

  Further Information Favourable Opinion