Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism
This trial is active, not recruiting.
|Conditions||ascending aorta aneurism, aortic insufficiency|
|Treatment||aortic valve reimplantation using valsalva prosthesis|
|Sponsor||Meshalkin Research Institute of Pathology of Circulation|
|Start date||January 2007|
|End date||December 2012|
|Trial size||60 participants|
|Trial identifier||NCT01456975, EVAPRO|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
Reimplantation procedure using Valsalva prosthesis
all causes of aortic valve replacement
time frame: before discharging (average of 2 weeks after surgery)
all causes of death after procedure
time frame: 6, 12, 24,36,48,60,72, 84, 96 months after procedure
Male or female participants from 18 years up to 80 years old.
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
|Official title||Reimplantation Procedure for Surgical Treatment of Ascending Aorta Aneurism With Concomitant Aortic Valve Insufficiency|
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