Aortic Insufficiency, Ascending Aorta Aneurism
Conditions
Keywords
Ascending aorta aneurism, Aortic insufficiency
Brief summary
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.
Interventions
PROCEDUREAortic valve reimplantation using Valsalva prosthesis
Aortic valve reimplantation (David procedure)using Valsalva prosthesis
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| all causes of aortic valve replacement | before discharging (average of 2 weeks after surgery) | Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| all causes of death after procedure | 6, 12, 24,36,48,60,72, 84, 96 months after procedure | Aortic insufficiency (AI) measured by echocardiography. If AI more than 2+, aortic valve replacement performed |
Countries
Russia
Outcome results
None listed