Aortic Root Enlargement in Aortic Valve Replacement

Assiut University

Status: Unknown

Conditions: Aortic Valve Replacement

Treatments: Procedure: procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT03603483

Aortic root enlargement

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 17 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Patients with sever aortic stenosis 1

Active Comparator group

Description:

Procedure: the patients will undergo aortic valve replacement with aortic root enlargement.

Treatment:

Procedure: procedure

Patients with sever aortic stenosis 2

Active Comparator group

Description:

Procedure: the patients will undergo conventional aortic valve replacement

Treatment:

Procedure: procedure