Aortic Root Enlargement in Aortic Valve Replacement

NCT03603483 | Unknown

• 1 other identifier: Aortic root enlargement
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aortic Valve Replacement

Keywords

patients- prosthesis mismatching

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients with sever aortic stenosis 1

ACTIVE COMPARATOR

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

Procedure: procedure

Patients with sever aortic stenosis 2

ACTIVE COMPARATOR

Procedure: the patients will undergo conventional aortic valve replacement

Procedure: procedure

Interventions

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

Patients with sever aortic stenosis 1; Patients with sever aortic stenosis 2

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• patients with sever aortic valve stenosis undergoing valve replacement surgery
• informed consent has been obtained

You may not qualify if:

• Planned off-pump cardiac surgery
• Patients required intra-aortic balloon pump
• under 17 years of age

Sponsors & Collaborators

• Assiut University: lead

Related 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. doi: 10.3889/oamjms.2016.098. Epub 2016 Sep 2.

  PMID: 27703574 BACKGROUND

• 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.

  PMID: 29167226 BACKGROUND

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Mohamed mahmoud ahmed, Doctor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed mahmoud ahmed, Doctor

CONTACT

01008332462; mohamedmahmoudclinic@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Aortic Root Enlargement in Patients with aortic stenosis with Small Aortic Annulus

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: July 27, 2018
• Study Start: January 15, 2019
• Primary Completion: March 28, 2019
• Study Completion: March 30, 2019
• Last Updated: January 9, 2019

Record last verified: 2019-01