APOLLO-EU study

• Research type

  Research Study

• Full title

  Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR Transfemoral System in patients with severe symptomatic mitral regurgitation.

• IRAS ID

  319225

• Contact name

  Simon Redwood

• Contact email

  simon.redwood@gstt.nhs.uk

• Sponsor organisation

  Medtronic Bakken Research Center B.V.

• Clinicaltrials.gov Identifier

  NCT05496998

• Duration of Study in the UK

  9 years, 11 months, 30 days

• Research summary

  Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation (leaking of blood backwards because the mitral valve of the heart doesn’t close properly) who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.

• REC name

  North of Scotland Research Ethics Committee 1

• REC reference

  22/NS/0148

• Date of REC Opinion

  28 Nov 2022

• REC opinion

  Favourable Opinion