Aortic Root Enlargement in Aortic Valve Replacement

Aortic Valve Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03603483
• Other study ID #: Aortic root enlargement
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: March 30, 2019

Study information

• Verified date: January 2019
• Source: Assiut University
• Contact: Mohamed mahmoud ahmed, Doctor
• Phone: 01008332462
• Email: mohamedmahmoudclinic[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 30, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Replacement
• Hypertrophy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

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. Epub 2016 Sep 2. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline 6 weeks postoperative