iCLAS™ for Persistent Atrial Fibrillation

  • End date
    Dec 9, 2022
  • participants needed
  • sponsor
    Adagio Medical
Updated on 23 March 2022
persistent atrial fibrillation


Clinical study to evaluate the safety and efficacy of the Adagio AF Cryoablation System (iCLAS™) in the ablation treatment of symptomatic, persistent atrial fibrillation (PsAF). Data will be used to support a pre-market application (PMA)


A staged pre-market, single-arm, clinical study designed to collect acute and long-term safety and efficacy data for the Adagio AF Cryoablation System (iCLAS™). Patient population will consist of symptomatic, persistent AF subjects completing a de novo ablation procedure. Enrollment will be 200 subjects at up to 20 global investigational sites. Subjects will receive an ablation with the ultra-low cryoablation device. Follow-up will include assessment at one, three, six, and twelve months.

Condition Persistent Atrial Fibrillation
Treatment Adagio AF Cryoablation System (iCLAS™)
Clinical Study IdentifierNCT04061603
SponsorAdagio Medical
Last Modified on23 March 2022


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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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