Aortic Root Enlargement in Aortic Valve Replacement

• Sponsor: Assiut University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03603483
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Anticipated Duration (Months): 2.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Replacement	Procedure: procedure	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Aortic Root Enlargement in Patients with aortic stenosis with Small Aortic AnnulusAortic Root Enlargement in Patients with aortic stenosis with Small Aortic Annulus
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Short Term Outcome of Aortic Root Enlargement in Management of Small Aortic Annulus Among Patients With Severe Valvular Aortic Stenosis
• Anticipated Study Start Date: Jan 15, 2019
• Anticipated Primary Completion Date: Mar 28, 2019
• Anticipated Study Completion Date: Mar 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Transthoracic echocardiographic measurement of transvalvular gradient across aortic valve prosthesis<25 mmHg [Baseline 6 weeks postoperative]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Mohamed mahmoud ahmed, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03603483
• Other Study ID Numbers: Aortic root enlargement
• First Posted: Jul 27, 2018
• Last Update Posted: Jan 9, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohamed mahmoud ahmed, Principal Investigator, Assiut University: patients- prosthesis mismatching
• Additional relevant MeSH terms: Hypertrophy

Study Results

No Results Posted as of Jan 9, 2019