Aortic Root Enlargement in Aortic Valve Replacement

Not Applicable

• Conditions: Aortic Valve Replacement
• Interventions: Procedure: procedure

• Registration Number: NCT03603483
• Lead Sponsor: Assiut University

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-27
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-09
• Study Start: 2019-01-15
• Primary Completion: 2019-03-28
• Study Completion: 2019-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 17-75 years old
• patients with sever aortic valve stenosis undergoing valve replacement surgery
• informed consent has been obtained

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Exclusion Criteria

• Planned off-pump cardiac surgery
• Patients required intra-aortic balloon pump
• under 17 years of age

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with sever aortic stenosis 1	procedure	Procedure: the patients will undergo aortic valve replacement with aortic root enlargement.
Patients with sever aortic stenosis 2	procedure	Procedure: the patients will undergo conventional aortic valve replacement

Primary Outcome Measures

Name	Time	Method
Transthoracic echocardiographic measurement of transvalvular gradient across aortic valve prosthesis<25 mmHg	Baseline 6 weeks postoperative	Mild stenosis gradient 25 mmHg, Moderate stenosis gradient 25-40 mmHg, Sever stenosis gradient \>40 mmHg