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Clinical Trials/NCT03603483
NCT03603483
Unknown
Not Applicable

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

Assiut University0 sites40 target enrollmentJanuary 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aortic Valve Replacement
Sponsor
Assiut University
Enrollment
40
Primary Endpoint
Transthoracic echocardiographic measurement of transvalvular gradient across aortic valve prosthesis<25 mmHg
Last Updated
7 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 15, 2019
End Date
March 30, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed mahmoud ahmed

Principal Investigator

Assiut University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Transthoracic echocardiographic measurement of transvalvular gradient across aortic valve prosthesis<25 mmHg

Time Frame: Baseline 6 weeks postoperative

Mild stenosis gradient 25 mmHg, Moderate stenosis gradient 25-40 mmHg, Sever stenosis gradient \>40 mmHg

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