Respond EDGE Protocol S2361

• Research type

  Research Study

• Full title

  RESPOND EDGE: Repositionable Lotus Edge™ Valve System – Post Market Evaluation of Real World Clinical Outcomes

• IRAS ID

  265282

• Contact name

  Rajesh Kharbanda

• Contact email

  Rajesh.Kharbanda@ouh.nhs.uk

• Sponsor organisation

  Boston Scientific International SAS

• Clinicaltrials.gov Identifier

  NCT04009720

• Duration of Study in the UK

  2 years, 11 months, 2 days

• Research summary

  RESPOND EDGE is a prospective, open-label, single-arm, multicenter, observational post-market surveillance study. Its objective is to collect clinical and device performance data with the LOTUS Edge™ Valve System as used in routine clinical practice for the treatment of patients with severe calcific aortic stenosis and at high risk for standard surgical valve replacement.

  Approximately 200 consented patients selected to be treated with the commercially available LOTUS Edge Valve System will be enrolled in RESPOND EDGE.

  Up to 20 study Sites in up to 15 countries will participate in RESPOND EDGE.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  19/SC/0507

• Date of REC Opinion

  31 Oct 2019

• REC opinion

  Further Information Favourable Opinion