MANTRA

• Research type

  Research Study

• Full title

  Corcym Mitral, Aortic aNd Tricuspid post-maRket Study in a reAl-world setting

• IRAS ID

  304706

• Contact name

  Max Baghai

• Contact email

  mbaghai@nhs.net

• Sponsor organisation

  Corcym S.r.l

• Clinicaltrials.gov Identifier

  NCT05002543

• Duration of Study in the UK

  14 years, 0 months, 17 days

• Research summary

  MANTRA is a prospective, multiple-arm, multi-center, global, post-market clinical follow-up study, and the main objective is to monitor ongoing safety and performance of the Corcym devices and accessories used for aortic, mitral and tricuspid valvular diseases in a real-world setting.
  This Clinical Investigation Master Plan (Master Protocol) is intended as an overarching umbrella protocol under which multiple sub-studies can be added as needed, following the approval of local Ethical Committees (EC)/Institutional review boards (IRB) and, if applicable, Competent Authorities (CA). Sub-studies may be conducted as single center or multi center studies depending on the scientific focus, questions, endpoints, or other considerations.
  Substudies under MANTRA Master Protocol are as follow:
  -MANTRA Aortic Sub-study
  -MANTRA Mitral Tricuspid Sub-study
  -MANTRA MEMO4D Sub-study

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  21/YH/0293

• Date of REC Opinion

  6 Jan 2022

• REC opinion

  Further Information Favourable Opinion