Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-01-01 @ 9:14 AM
Study NCT ID:
NCT05426759
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2022-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation
Sponsor:
Atrian Medical Ltd.
Organization:
Study Overview
Official Title:
Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2024-06
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:
Neural-AF-2
Brief Summary:
A prospective single-arm study of ganglionated plexi ablation in cardiothoracic surgery patients with a history of atrial fibrillation.
Detailed Description:
This study assesses the use of electroporation/pulsed field ablation (PFA) to selectively ablate ganglionated plexi in cardiothoracic surgery patients with atrial fibrillation. The PFA treatment will be performed in up to 12 patients with a history of paroxysmal atrial fibrillation. The primary end point will be recurrence of atrial fibrillation out to 1 year follow-ups.
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?: