Aortic Root Enlargement in Aortic Valve Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2019-03-30

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.

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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

Conditions

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Aortic Valve Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Aortic Root Enlargement in Patients with aortic stenosis with Small Aortic Annulus

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with sever aortic stenosis 1

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

Group Type ACTIVE_COMPARATOR

procedure

Intervention Type PROCEDURE

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

Patients with sever aortic stenosis 2

Procedure: the patients will undergo conventional aortic valve replacement

Group Type ACTIVE_COMPARATOR

procedure

Intervention Type PROCEDURE

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

Interventions

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procedure

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

Intervention Type PROCEDURE