Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-01-01 @ 2:59 AM
Study NCT ID:
NCT04061603
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2019-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iCLAS™ for Persistent Atrial Fibrillation
Sponsor:
Adagio Medical
Organization:
Study Overview
Official Title:
iCLAS™ for Persistent Atrial Fibrillation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: