Aortic Root Enlargement in Aortic Valve Replacement

Study Overview
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Brief Summary
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Aortic valve disease is a progressive illness that varies from minor valve thickening lacking obstruction of blood stream to severe calcification and alteration of the valve leading to weakened leaflet motion. Aortic valve replacement is a usual operation but can be complicated by a small aortic annulus requiring the insertion of an aortic valve prosthesis. Prosthesis-patient discrepancy results in worse outcomes.

Detailed Description
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Prosthesis-patient discrepancy results in worse outcomes, including elevated left ventricular work, decreased left ventricular mass regression, and has also been linked with high mortality. Therefore, Aortic root posterior enlargement by autologous fixed pericardium to insert an Aortic valve prosthesis with size suitable to patient body surface area to avoid the previous worse outcome of patient prosthesis mismatch. In this study the investigators will try to identify the benefits of Aortic Root Enlargement in management of Small Aortic Annulus in Patients with severe valvular aortic stenosis

Official Title
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Short Term Outcome of Aortic Root Enlargement in Management of Small Aortic Annulus Among Patients With Severe Valvular Aortic Stenosis

Conditions
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Aortic Valve Replacement

Intervention / Treatment
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* Procedure: procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 17-75 years old patients with sever aortic valve stenosis undergoing valve replacement surgery informed consent has been obtained Exclusion Criteria: Planned off-pump cardiac surgery Patients required intra-aortic balloon pump under 17 years of age

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Aortic Root Enlargement in Patients with aortic stenosis with Small Aortic Annulus
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with sever aortic stenosis 1<br>Procedure: the patients will undergo aortic valve replacement with aortic root enlargement. | Procedure: procedure<br>* Patients of sever aortic stenosis 1: increase the diameter of aortic anulus by prosthetic patch or pericardial patch. Patients of sever aortic stenosis 1:only conventional aortic valve prosthesis will be used<br>|
| Active Comparator: Patients with sever aortic stenosis 2<br>Procedure: the patients will undergo conventional aortic valve replacement | Procedure: procedure<br>* Patients of sever aortic stenosis 1: increase the diameter of aortic anulus by prosthetic patch or pericardial patch. Patients of sever aortic stenosis 1:only conventional aortic valve prosthesis will be used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transthoracic echocardiographic measurement of transvalvular gradient across aortic valve prosthesis<25 mmHg | Mild stenosis gradient 25 mmHg, Moderate stenosis gradient 25-40 mmHg, Sever stenosis gradient >40 mmHg | Baseline 6 weeks postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patients- prosthesis mismatching