NCT04061603

iCLAS™ for Persistent Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Adagio Medical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Adagio AF Cryoablation System (iCLAS™)	Endovascular ablation of the left and right atrium

Timeline

• Start date: 2019-12-09
• Primary completion: 2023-08-30
• Completion: 2024-08-30
• First posted: 2019-08-20
• Last updated: 2026-04-13

Locations

21 sites across 4 countries: United States, Belgium, Canada, Netherlands

Regulatory

• FDA-regulated device study