Study of Aortic Root Reimplantation Procedure (STAR)

Meshalkin Research Institute of Pathology of Circulation

Status: Completed

Conditions: Ascending Aortic Aneurism; Aortic Valve Insufficiency

Treatments: Procedure: Aortic Root Reimplantation Procedure; Procedure: Aortic Valve Reimplantation Procedure

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01787604

STAR

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Aortic Root Reimplantation Procedure

Active Comparator group

Description:

Aortic Root Reimplantation Procedure

Treatment:

Procedure: Aortic Root Reimplantation Procedure

Aortic Valve Reimplantation Procedure

Active Comparator group

Description:

Aortic Valve Reimplantation Procedure

Treatment:

Procedure: Aortic Valve Reimplantation Procedure