Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism (EPSTAAA)

Meshalkin Research Institute of Pathology of Circulation

Status: Unknown

Conditions: Aortic Insufficiency; Ascending Aorta Aneurism

Treatments: Procedure: Aortic valve reimplantation using Valsalva prosthesis

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01456975

EVAPRO

Details and patient eligibility

About

The investigators expect that the using of prothesis with sinuses has more benefits for long term competence and condition of aortic valve than the using of straight prothesis.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aortic insufficiency 2+
2. Ascending aorta size more than 5 cm
3. Ascending aorta size more than 4,5 cm (Marfan syndrome)
4. Good conditions of aortic cusps

Exclusion criteria

1. Aortic annulus more than 30 mm
2. Aortic cusps destruction
3. Critical aortic cusps elongation
4. Aortic root dissection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 1 patient group

Valsalva

Experimental group

Description:

Reimplantation procedure using Valsalva prosthesis

Treatment:

Procedure: Aortic valve reimplantation using Valsalva prosthesis