VT Cryoablation System Post-Market Clinical Follow-up

• Research type

  Research Study

• Full title

  Adagio Medical VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study Protocol Number CS-190

• IRAS ID

  326018

• Contact name

  Neil Srinivasan

• Contact email

  neil.srinivasan2@nhs.net

• Sponsor organisation

  Adagio Medical Inc

• Clinicaltrials.gov Identifier

  NCT06384599

• Duration of Study in the UK

  1 years, 2 months, 29 days

• Research summary

  The purpose of this Post-Market Clinical Follow-Up (PMCF) is to collect clinical data for the Adagio Medical vCLAS™ Cryoablation System when used as intended (per Instructions for Use, the Declaration of Conformity and approved labelling). The Adagio Medical vCLAS™ Cryoablation System will be used to treat monomorphic Ventricular Arrhythmias.
  This study is a post-market follow up (after commercialization) to collect real world safety and performance data of the vCLAS Cryoablation system in the approved indication.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  24/NW/0266

• Date of REC Opinion

  1 Nov 2024

• REC opinion

  Further Information Favourable Opinion