Study of Aortic Root Reimplantation Procedure

Not Applicable

Completed

• Conditions: Aortic Valve Insufficiency; Ascending Aortic Aneurism
• Interventions: Procedure: Aortic Root Reimplantation Procedure; Procedure: Aortic Valve Reimplantation Procedure

• Registration Number: NCT01787604
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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 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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2013-01-30
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-08
• Primary Completion: 2015-11-20
• Study Completion: 2015-11-20
• Results First Submitted: 2017-09-07
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-10
• Last Update Submitted: 2019-03-10
• Results First Posted: 2019-06-10
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Aortic insufficiency 2+
• Ascending aorta or aortic root of greater than 4.5 cm (> 4.0 cm in Marfan syndrome)
• Good conditions of aortic cusps

Exclusion Criteria

• Aortic annulus more than 32 mm
• Aortic cusps destruction
• Critical aortic cusps elongation
• Aortic root dissection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aortic Root Reimplantation Procedure	Aortic Root Reimplantation Procedure	Aortic Root Reimplantation Procedure
Aortic Valve Reimplantation Procedure	Aortic Valve Reimplantation Procedure	Aortic Valve Reimplantation Procedure

Primary Outcome Measures

Name	Time	Method
Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier)	up to 4 yeras	Estimated percentage of participants free from aortic insufficiency (AI) more than 2+ measured by echocardiography for a 4 years after treatment..

Secondary Outcome Measures

Name	Time	Method
Survival (Percentage, Kaplan-Meier)	up to 4 yeras	Estimated percentage of alive participants for 4 years after treatment.

Trial Locations

Locations (1)

Meshalkin State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation