Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT03604432
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2018-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Prophylactic Maze to Prevent Atrial Fibrillation in Adult Cardiac Surgery
Sponsor:
Corewell Health West
Organization:
Study Overview
Official Title:
Prophylactic Limited Left Sided Maze Procedure to Prevent Post-operative Atrial Fibrillation in Adult Cardiac Surgery Patients
Status:
COMPLETED
Status Verified Date:
2023-10
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:
PREVENT-AF
Brief Summary:
This study will look at performing a prophylactic limited left sided maze procedure during concomitant adult cardiac surgery to prevent the common occurrence of postoperative atrial fibrillation.
Detailed Description:
This is a prospective, single site, randomized, small feasibility study using a FDA approved device for a new indication. Subjects undergoing a CABG, AVR, or CABG/AVR will be randomized 1 to 1 to a control or treatment group. The control group will undergo their index cardiac surgery procedure only. The treatment group will undergo their index cardiac procedure along with a limited left sided maze procedure. The maze procedure will be done with the Atricure synergy ablation system. This is an FDA approved device that will be used for this new indication.
The left sided limited maze procedure will consist of pulmonary vein isolation and removal of the left atrial appendage.
A total of 60 subjects will be enrolled in this study at a single site.
The left sided limited maze procedure will consist of pulmonary vein isolation and removal of the left atrial appendage.
A total of 60 subjects will be enrolled in this study at a single site.
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?:
True
Is an FDA AA801 Violation?: