Aortic Root Enlargement in Aortic Valve Replacement
Primary Purpose
Aortic Valve Replacement
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
procedure
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Replacement focused on measuring patients- prosthesis mismatching
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
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
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
No
Studies a U.S. FDA-regulated Device Product
No
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
No
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
Email
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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