Ignite Creation Date:
2024-05-06 @ 1:19 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01787604
Status:
COMPLETED
Last Update Posted:
2019-06-10
First Post:
2013-01-30
Brief Title:
Study of Aortic Root Reimplantation Procedure
Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Organization:
Meshalkin Research Institute of Pathology of Circulation
Study Overview
Official Title:
Superiority Trial of Aortic Root Reimplantation Procedure Versus Aortic Valve Reimplantation Procedure
Status:
COMPLETED
Status Verified Date:
2019-03
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:
STAR
Brief Summary:
Authors hypothesize that aortic root reimplantation procedure is superior over standard aortic valve reimplantation procedure in the incidence of aortic valve replacement
Detailed Description:
A single blind prospective randomized superiority study is conducted Our hypothesis is that there is difference in the incidence of aortic valve replacement between the standard aortic valve reimplantation procedure and aortic root reimplantation procedure more than 211 If there is truly difference between groups Aortic Root Reimplantation Procedure and Aortic Valve Reimplantation Procedure then total 64 patients for both groups are required to be 80 sure that the upper limit of a one-sided 95 confidence interval would reveal a difference in favour of the Aortic Root Reimplantation Procedure of 211 The blinding process is applied to a patient who is informed about received valve-sparing operation but dont know the type of the last The study was approved by Institutional Review Board Depending on a type of the procedure the patients are divided into two groups Aortic Root Reimplantation Procedure group includes 32 patients and Aortic Valve Reimplantation Procedure group consists of 32 patients Randomization is conducted intraoperatively by using accidental sampling after examining the aortic valve and making a decision on the possibility of a valve-sparing operation
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