Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00173186
Status:
UNKNOWN
Last Update Posted:
2005-09-15
First Post:
2005-09-12
Brief Title:
Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Aortic Regurgitation After Surgical Repair of Outlet-Type Ventricular Septal Defect
Status:
UNKNOWN
Status Verified Date:
2005-06
Last Known Status:
RECRUITING
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:
The major risk factors of aortic valve replacement in three outlet types VSD after surgical repair were the severity of preoperative AR and older operation age For those patients with less than moderate degree AR preoperatively AR progressed rarely and all in those with aortic valvar and subvalvar anomalies
Detailed Description:
Progression of aortic regurgitation AR in repaired outlet juxta-arterial muscular outlet and perimembranous outlet ventricular septal defect VSD remains unclear
From 1987 to 2002 411 patients with complete follow-up after repair of outlet VSD constituted the study population Study end point was aortic valve replacement or mortality
Aortic valve replacement was performed in seventeen patients 41 in whom logistic regression showed only the severity of preoperative AR and age at VSD repair as the predictors After excluding the eleven patients with endocarditis from analysis there were 377 patients with none to mild AR Group I and 23 with moderate to severe AR Group II preoperatively Total follow-up was 2230 person-years After VSD repair the 5- and 10-year freedom from aortic valve replacement in Group I was 100 and in Group II 502 In Group II ten patients received aortic valve replacement and 8 underwent valvuloplasty with VSD repair One patient needed valve replacement four years later Age at VSD repair was the predictor for aortic valve replacement In Group I AR progressed in four patients 12 two juxta-arterial and two perimembranous outlet 35 to 79 years later and was associated with aortic valvar or subvalvar anomalies The event-free curves in three outlet types VSD showed no differences
Although AR progressed rarely probably not in muscular outlet type in repaired outlet types VSD with none to mild preoperative AR in the presence of aortic valvar or subvalvar anomalies early surgical repair of the VSD is still warranted
From 1987 to 2002 411 patients with complete follow-up after repair of outlet VSD constituted the study population Study end point was aortic valve replacement or mortality
Aortic valve replacement was performed in seventeen patients 41 in whom logistic regression showed only the severity of preoperative AR and age at VSD repair as the predictors After excluding the eleven patients with endocarditis from analysis there were 377 patients with none to mild AR Group I and 23 with moderate to severe AR Group II preoperatively Total follow-up was 2230 person-years After VSD repair the 5- and 10-year freedom from aortic valve replacement in Group I was 100 and in Group II 502 In Group II ten patients received aortic valve replacement and 8 underwent valvuloplasty with VSD repair One patient needed valve replacement four years later Age at VSD repair was the predictor for aortic valve replacement In Group I AR progressed in four patients 12 two juxta-arterial and two perimembranous outlet 35 to 79 years later and was associated with aortic valvar or subvalvar anomalies The event-free curves in three outlet types VSD showed no differences
Although AR progressed rarely probably not in muscular outlet type in repaired outlet types VSD with none to mild preoperative AR in the presence of aortic valvar or subvalvar anomalies early surgical repair of the VSD is still warranted
Study Oversight
Has Oversight DMC:
None
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?:
None