iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
Reason given: Adagio Medical no longer manufactures the iCLAS Cryoablation System
Key facts
- Where
- Nieuwegein and Rotterdam, NetherlandsSee the 2 sites
Where in Netherlands
- St. Antonius ZiekenhuisNieuwegein, NetherlandsNo longer taking part
- Erasmus MCRotterdam, NetherlandsNo longer taking part
Trial details
- Who runs it
- Adagio Medical
- Trial code
- NCT05416086
- Record updated
- 13 April 2026
- Original description
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).Read full original descriptionShow less
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).
Inclusion: Subject is ≥ 18 years of age; Planned ablation procedure according to the indication for use of the commercially available Adagio iCLAS™ Cryoablation System; Subject willing to comply with study requirements and give informed consent.
Exclusion: Subject is enrolled in a study that has not been approved for concurrent enrollment by the sponsor; Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than one year, extensive travel away from the research center); In the opinion of the Investigator, any known contraindication to an atrial ablation procedure with the Adagio iCLAS™ Cryoablation System as indicated in the device Instructions For Use (IFU).