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iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
Sponsor: Adagio Medical
Summary
A prospective, single-arm, multi-center study designed to collect real world safety and performance data of the Adagio Medical iCLAS Cryoablation System in the treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation (PsAF), and Atrial Flutter (AFL).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
91
Start Date
2021-09-03
Completion Date
2025-01-28
Last Updated
2026-04-13
Healthy Volunteers
Yes
Conditions
Interventions
cryoablation procedure using the iCLAS Cryoablation System
all subjects will receive a cryoablation procedure using the iCLAS Cryoablation System (catheter, stylets, and console) and warming balloon
Locations (4)
Onze-Lieve-Vrouw Hospital Aalst (OLV)
Aalst, Belgium
Universitatsklinikum Erlangen
Erlangen, Germany
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Erasmus MC
Rotterdam, Netherlands