Aortic Root Enlargement in Aortic Valve Replacement

January 8, 2019 updated by: Mohamed mahmoud ahmed, Assiut University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients with sever aortic stenosis 1
Procedure: the patients will undergo aortic valve replacement with aortic root enlargement.
Procedure: 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
Active Comparator: Patients with sever aortic stenosis 2
Procedure: the patients will undergo conventional aortic valve replacement
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline 6 weeks postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mohamed mahmoud ahmed, Doctor, Lecturer of cardiothoracic surgery, Faculty of Medicine, Assiut University, Assiut, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 15, 2019

Primary Completion (Anticipated)

March 28, 2019

Study Completion (Anticipated)

March 30, 2019

Study Registration Dates

First Submitted

March 8, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

January 9, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aortic root enlargement

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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