Superiority Trial of Aortic Root Reimplantation Procedure Versus Aortic Valve Reimplantation Procedure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ascending Aortic Aneurism
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Authors hypothesize that aortic root reimplantation procedure is superior over standard aortic valve reimplantation procedure in the incidence of aortic valve replacement.
Detailed Description
A single blind prospective randomized superiority study is conducted. Our hypothesis is that there is difference in the incidence of aortic valve replacement between the standard aortic valve reimplantation procedure and aortic root reimplantation procedure more than 21.1%. If there is truly difference between groups (Aortic Root Reimplantation Procedure and Aortic Valve Reimplantation Procedure), then total 64 patients for both groups are required to be 80% sure that the upper limit of a one-sided 95% confidence interval would reveal a difference in favour of the Aortic Root Reimplantation Procedure of 21.1%. The blinding process is applied to a patient, who is informed about received valve-sparing operation, but don't know the type of the last. The study was approved by Institutional Review Board. Depending on a type of the procedure, the patients are divided into two groups: Aortic Root Reimplantation Procedure group includes 32 patients and Aortic Valve Reimplantation Procedure group consists of 32 patients. Randomization is conducted intraoperatively by using accidental sampling after examining the aortic valve and making a decision on the possibility of a valve-sparing operation.
Investigators
Dmitry Khvan
cardiac surgeon
Meshalkin Research Institute of Pathology of Circulation
Eligibility Criteria
Inclusion Criteria
- •Aortic insufficiency 2+
- •Ascending aorta or aortic root of greater than 4.5 cm (\> 4.0 cm in Marfan syndrome)
- •Good conditions of aortic cusps
Exclusion Criteria
- •Aortic annulus more than 32 mm
- •Aortic cusps destruction
- •Critical aortic cusps elongation
- •Aortic root dissection
Outcomes
Primary Outcomes
Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier)
Time Frame: up to 4 yeras
Estimated percentage of participants free from aortic insufficiency (AI) more than 2+ measured by echocardiography for a 4 years after treatment..
Secondary Outcomes
- Survival (Percentage, Kaplan-Meier)(up to 4 yeras)