Stopped: Adagio Medical no longer manufactures the iCLAS Cryoablation System
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).
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Primary outcome - freedom from AF
Timeframe: 12 months
Primary outcome - freedom from AF/AT/AFL
Timeframe: 12 months
Primary outcome - freedom from Device/Procedure Related Adverse Events
Timeframe: during procedure and up to 12-month follow up