Study of Aortic Root Reimplantation Procedure — STAR  

Aortic Valve Insufficiency Clinical Trial

Official title: Superiority Trial of Aortic Root Reimplantation Procedure Versus Aortic Valve Reimplantation Procedure

Status Completed

Clinical Trial Summary

Authors hypothesize that aortic root reimplantation procedure is superior over standard aortic valve reimplantation procedure in the incidence of aortic valve replacement.

Clinical Trial 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 21.1%. 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 21.1%. The blinding process is applied to a patient, who is informed about received valve-sparing operation, but don't 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. ;

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Valve Insufficiency
• Ascending Aortic Aneurism

• NCT number: NCT01787604
• Study type: Interventional
• Source: Meshalkin Research Institute of Pathology of Circulation
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Completion date: November 20, 2015