Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-31 @ 11:54 PM
Study NCT ID:
NCT05113056
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2021-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AcQForce Pulsed Field Ablation-CE
Sponsor:
Acutus Medical
Organization:
Study Overview
Official Title:
The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)
Status:
COMPLETED
Status Verified Date:
2023-11
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:
PFA-AF
Brief Summary:
The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)
Detailed Description:
This clinical study is designed to evaluate the safety and performance of the PFA System in the ablation treatment of atrial fibrillation (AF). Data will be used to support regulatory submissions.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: