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).
This Post-Market Clinical Follow-up (PMCF) study continues collecting additional information about the Adagio Medical iCLAS™ Cryoablation System in real world clinical settings.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
all subjects will receive a cryoablation procedure using the iCLAS Cryoablation System (catheter, stylets, and console) and warming balloon
Onze-Lieve-Vrouw Hospital Aalst (OLV)
Aalst, Belgium
RECRUITINGUniversitatsklinikum Erlangen
Erlangen, Germany
RECRUITINGSt. Antonius Ziekenhuis
Nieuwegein, Netherlands
RECRUITINGPrimary outcome - freedom from AF
Freedom from Atrial Fibrillation (AF) recurrence during the 12-months follow-up period.
Time frame: 12 months
Primary outcome - freedom from AF/AT/AFL
Freedom from Atrial Arrhythmia at 12-months
Time frame: 12 months
Primary outcome - freedom from Device/Procedure Related Adverse Events
Freedom from Device / Procedure Related Adverse Events during and after the ablation procedure through12-month follow up
Time frame: during procedure and up to 12-month follow up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Erasmus MC
Rotterdam, Netherlands
RECRUITING