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Aortic Root Enlargement in Aortic Valve Replacement

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03603483
Enrollment
40
Registered
2018-07-27
Start date
2019-01-15
Completion date
2019-03-30
Last updated
2019-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Replacement

Keywords

patients- prosthesis mismatching

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

Interventions

PROCEDUREprocedure

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
17 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Transthoracic echocardiographic measurement of transvalvular gradient across aortic valve prosthesis<25 mmHgBaseline 6 weeks postoperativeMild stenosis gradient 25 mmHg, Moderate stenosis gradient 25-40 mmHg, Sever stenosis gradient \>40 mmHg

Contacts

Primary ContactMohamed mahmoud ahmed, Doctor
mohamedmahmoudclinic@gmail.com01008332462

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026