iCLAS™ Post-Market Clinical Follow-up Study

• Research type

  Research Study

• Full title

  iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study; CS-086

• IRAS ID

  316117

• Contact name

  Riyaz Somani

• Contact email

  Riyaz.Somani@uhl-tr.nhs.uk

• Sponsor organisation

  Adagio Medical Inc

• Clinicaltrials.gov Identifier

  NCT05416086

• Duration of Study in the UK

  1 years, 6 months, 12 days

• Research summary

  The iCLAS Cryoablation System has demonstrated safety and performance and received CE marking for treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation (PsAF), and Atrial Flutter (AFL) by ablation of arrhythmogenic tissue that drives and maintains these arrhythmias.

  This study is a post-market follow up (after commercialization) to collect real world safety and performance data of the iCLAS Cryoablation system in the approved indication (treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation (PsAF), and Atrial Flutter (AFL)).

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  22/NW/0271

• Date of REC Opinion

  22 Nov 2022

• REC opinion

  Further Information Favourable Opinion