iCLAS™ for Persistent Atrial Fibrillation

Status Active, not recruiting

Clinical Trial Summary

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)

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04061603
Study type	Interventional
Source	Adagio Medical
Contact
Status	Active, not recruiting
Phase	N/A
Start date	December 9, 2019
Completion date	August 30, 2024

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See also
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