Study of Aortic Root Reimplantation Procedure

Study 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.

Official Title
-----------------
Superiority Trial of Aortic Root Reimplantation Procedure Versus Aortic Valve Reimplantation Procedure

Conditions
-----------------
Ascending Aortic Aneurism, Aortic Valve Insufficiency

Intervention / Treatment
-----------------
* Procedure: Aortic Root Reimplantation Procedure
* Procedure: Aortic Valve Reimplantation Procedure


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aortic Root Reimplantation Procedure<br>Aortic Root Reimplantation Procedure | Procedure: Aortic Root Reimplantation Procedure<br>* Modified Florida Sleeve.<br>* Other names: Modified Florida Sleeve.;|
| Active Comparator: Aortic Valve Reimplantation Procedure<br>Aortic Valve Reimplantation Procedure | Procedure: Aortic Valve Reimplantation Procedure<br>* David I<br>* Other names: David I;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier) | Estimated percentage of participants free from aortic insufficiency (AI) more than 2+ measured by echocardiography for a 4 years after treatment.. | up to 4 yeras | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival (Percentage, Kaplan-Meier) | Estimated percentage of alive participants for 4 years after treatment. | up to 4 yeras | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Valve repair, Valve-sparing