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Aortic Root Enlargement in Aortic Valve Replacement

Primary Purpose

Aortic Valve Replacement

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

procedure

About this trial

This is an interventional treatment trial for Aortic Valve Replacement focused on measuring patients- prosthesis mismatching

Eligibility Criteria

17 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Patients with sever aortic stenosis 1

Patients with sever aortic stenosis 2

Arm Description

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

Procedure: the patients will undergo conventional aortic valve replacement

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03603483

First Posted

March 8, 2018

Last Updated

January 8, 2019

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03603483

Brief Title

Aortic Root Enlargement in Aortic Valve Replacement

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 15, 2019 (Anticipated)

Primary Completion Date

March 28, 2019 (Anticipated)

Study Completion Date

March 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Replacement

Keywords

patients- prosthesis mismatching

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with sever aortic stenosis 1

Arm Type

Active Comparator

Arm Description

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

Arm Title

Patients with sever aortic stenosis 2

Arm Type

Active Comparator

Arm Description

Procedure: the patients will undergo conventional aortic valve replacement

Intervention Type

Procedure

Intervention Name(s)

procedure

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline 6 weeks postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed mahmoud ahmed, Doctor

Phone

01008332462

mohamedmahmoudclinic@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed mahmoud ahmed, Doctor

Organizational Affiliation

Lecturer of cardiothoracic surgery, Faculty of Medicine, Assiut University, Assiut, Egypt

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

27703574

Citation

Dumani S, Likaj E, Dibra L, Llazo S, Refatllari A. Aortic Annular Enlargement during Aortic Valve Replacement. Open Access Maced J Med Sci. 2016 Sep 15;4(3):455-457. doi: 10.3889/oamjms.2016.098. Epub 2016 Sep 2.

Results Reference

background

PubMed Identifier

29167226

Citation

Rocha RV, Manlhiot C, Feindel CM, Yau TM, Mueller B, David TE, Ouzounian M. Surgical Enlargement of the Aortic Root Does Not Increase the Operative Risk of Aortic Valve Replacement. Circulation. 2018 Apr 10;137(15):1585-1594. doi: 10.1161/CIRCULATIONAHA.117.030525. Epub 2017 Nov 22.

Results Reference

background

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Aortic Root Enlargement in Aortic Valve Replacement

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