Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism
Not Applicable
- Conditions
- Aortic InsufficiencyAscending Aorta Aneurism
- Interventions
- Procedure: Aortic valve reimplantation using Valsalva prosthesis
- Registration Number
- NCT01456975
- Lead Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Aortic insufficiency 2+
- Ascending aorta size more than 5 cm
- Ascending aorta size more than 4,5 cm (Marfan syndrome)
- Good conditions of aortic cusps
Exclusion Criteria
- Aortic annulus more than 30 mm
- Aortic cusps destruction
- Critical aortic cusps elongation
- Aortic root dissection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Valsalva Aortic valve reimplantation using Valsalva prosthesis Reimplantation procedure using Valsalva prosthesis
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Dmitry A. Sirota
🇷🇺Novosibirsk, Russian Federation