Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism

Meshalkin Research Institute of Pathology of Circulation60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Ascending Aorta Aneurism Aortic Insufficiency

Interventions

Aortic valve reimplantation using Valsalva prosthesisPROCEDURE

Aortic valve reimplantation (David procedure)using Valsalva prosthesis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Dmitry A. Sirota

Novosibirsk, Russia

Outcomes

Primary Outcomes

all causes of aortic valve replacement

Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed

Time frame: before discharging (average of 2 weeks after surgery)

Secondary Outcomes

all causes of death after procedure

Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed

Time frame: 6, 12, 24,36,48,60,72, 84, 96 months after procedure

Data from ClinicalTrials.gov

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