Trifecta GT

• Research type

  Research Study

• Full title

  Trifecta GT Post Market Clinical Follow-up

• IRAS ID

  221373

• Contact name

  Malcolm Dalrymple-Hay

• Contact email

  malcolm.dalrymple-hay@nhs.net

• Sponsor organisation

  St. Jude Medical Inc.

• Clinicaltrials.gov Identifier

  NCT03016169

• Duration of Study in the UK

  6 years, 0 months, 0 days

• Research summary

  The objective of this study is to evaluate the safety and performance of the Trifecta™ GT valve through 5 year follow-up in a prospective, multi-center, real-world setting. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe. This study is sponsored by St. Jude Medical.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  17/SW/0035

• Date of REC Opinion

  24 Feb 2017

• REC opinion

  Favourable Opinion