Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT01791218
Status:
TERMINATED
Last Update Posted:
2020-09-02
First Post:
2013-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Pulmonary Vein Isolation Efficiency Study
Sponsor:
Kuopio University Hospital
Organization:
Study Overview
Official Title:
Concomitant Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation Patients Undergoing Elective Coronary Artery Bypass Grafting and Aortic Valve Replacement for Aortic Stenosis: a Prospective Study
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not enough patients for study arms
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIN-PVI
Brief Summary:
A substantial proportion of patients undergoing elective coronary artery bypass grafting have a history of paroxysmal atrial fibrillation. Paroxysmal atrial fibrillation has adverse short-and long term postoperative effects. Pulmonary vein isolation (PVI) seems to be effective treatment for paroxysmal atrial fibrillation. PVI can be done concomitantly with coronary artery bypass grafting, aortic valve replacement for aortic stenosis and combination of them. Procedure is well defined and safe.
There is a lack of convincing evidence of the effect on postoperative atrial fibrillation burden, quality of life and symptoms especially in correlation with atrial fibrillation paroxysms.
There is a lack of convincing evidence of the effect on postoperative atrial fibrillation burden, quality of life and symptoms especially in correlation with atrial fibrillation paroxysms.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: