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Aortic Valve Sparing Root Replacement Versus Bentall

Primary Purpose

Aortic Root Aneurysm, Aortic Root Dissection

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aortic valve sparing operation
Bentall operation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Root Aneurysm focused on measuring Valve sparing aortic root replacement

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Ascending aorta or aortic root aneurysm(size more than 5 cm or 4.5 cm in Marfan syndrome).
  2. Ascending aorta or aortic root dissection.
  3. Aortic regurgitation 2+.
  4. Good condition of aortic cusps.

Exclusion Criteria:

  1. The left ventricular ejection fraction less than 40 %.
  2. Aortic aneurysm or dissection without aortic regurgitation.
  3. Aortic stenosis.
  4. Patients with extensive aortic root destruction because of aortic root infection.
  5. Internal carotid artery stenosis more than 70%.

Sites / Locations

  • Assiut universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A(aortic valve sparing operation)

B(Bentall operation)

Arm Description

Undergo aortic valve sparing root replacement operation

Undergo Bentall operation

Outcomes

Primary Outcome Measures

Number of subjects who die
Number of subjects who die either intraoperative or intrahospital

Secondary Outcome Measures

Grade of aortic valve regurgitation
Grade of postoperative aortic valve regurgitation by echocardiography
Mean gradient(mmgh) on the aortic valve
Mean gradient(mmgh) on the aortic valve by echocardiography
Thromboembolism/bleeding
Number of subjects who present by Thromboembolism/bleeding
Prosthetic/native valve endocarditis
Number of subjects who present with prosthetic/native valve endocarditis

Full Information

First Posted
July 12, 2018
Last Updated
October 12, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03604913
Brief Title
Aortic Valve Sparing Root Replacement Versus Bentall
Official Title
Aortic Valve-sparing Root Replacement Operation Versus Bentall Operation - Early and Midterm Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (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
This study was designed to evaluate the hypothesis that the operative and midterm results of valve-sparing aortic root replacement are equivalent to those of the Bentall. Objective 1: Evaluate short-term (one-to-six months) and mid-term (six-to-forty-eight months) results of aortic valve-sparing procedures. Objective 2: Compare the results of aortic valve-sparing procedures with the group of patients undergoing Bentall procedures during the same period. Objective 3: Assess outcomes of both procedures through evaluation of postoperative: A) primary outcome measures: Intraoperative or intrahospital death. Reexploration for bleeding. Reoperation rate. Grade of aortic valve regurgitation (0-4). B)secondary outcome measures: Grade of aortic valve regurgitation (0-4). Mean gradient on the aortic valve(mmHg). Thromboembolism / bleeding. Prosthetic/native valve endocarditis. 2-year mortality
Detailed Description
The aortic root is a complex structure whose single components are of paramount importance in assuring proper functioning of the aortic valve. In fact, opening and closing behaviors of the aortic leaflets are regulated by the interaction of the various components of the aortic root as well as by the characteristics of blood flow. Operation was the only possible surgical solution for diseases involving the sinuses of Valsalva and the aortic valve. Even in experienced hands, the perioperative mortality was not insignificant. However, since the introduction of the exclusion technique, the mortality and major morbidity of aortic root replacement have seen a dramatic decline. In recent years, groups focused on aortic disease have reported elective operative mortality less than 5%, with a marked decline in the incidence of stroke, hemorrhage, and other major postoperative complications. The composite graft replacement, as originally reported by Bentall and De Bono in 1968, has become a milestone in proximal aortic surgery, by providing the solution to a surgical problem that was a formidable challenge for that era. From the original report, many relevant scientific papers continued to address both the disease (dilatation or dissection of the proximal aorta, involving the aortic root and, often, the aortic valve) and its surgical correction. This ongoing attention led to several major refinements of the original technique and to the development of improved prosthetic material. All these efforts were aimed at the solution of two major problems affecting the original inclusion-wrapping technique: pseudoaneurysm formation (usually at the site of coronary anastomosis) and transprosthetic bleeding due to excessive porosity of the vascular prosthesis. For many years, however, little attention was paid to the fact that, in many instances, the aortic valve was intrinsically healthy, and nonetheless was substituted, thus unnecessarily exposing the patient to the risk of valve-related complications. The analysis of the normal anatomy and physiology of aortic root is the basis for establishing the surgical transition, in selected cases, from aortic root replacement to aortic valve-sparing operation. In 1983, however, Dr Yacoub addressed the issue of aortic insufficiency secondary to dilatation of the sinotubular junction and he proposed to resect the entire diseased aortic wall, preserving the valve with its commissural posts. A properly tailored vascular prosthesis, with three semicircular tongues, was then sutured to a small rim of the aortic wall just above the aortic annulus, following its three-cusp, crown-shaped line. The entire aortic root was therefore remodelled, thus justifying the appellation of remodelling technique, with reconstruction of a bulged root and a well defined sinotubular junction. Approximately 10 years later, Dr David introduced the aortic valve-sparing reimplantation technique by means of which the valve remnants prepared in a similar manner were reimplanted inside a cylindrical Dacron conduit. The introduction of techniques for valve-sparing aortic root replacement over 20 years ago has allowed for the preservation of healthy aortic valve in patients with severely diseased aortic roots. Moreover, an attempt is made to reconstruct as closely as possible all anatomic components of the aortic root, thus restoring the physiologic behaviour of the aortic valve leaflets within the reshaped root. By maintaining native aortic valve function, potential adverse events related to the use of either a mechanical or a bioprosthetic valve are avoided, including eliminating the lifelong burden of anticoagulation or the risk of structural valve deterioration. As such, valve-sparing aortic root replacement is an attractive therapy for aortic root pathology with preservation of the native aortic valve. Limited data exist comparing valve-sparing aortic root replacement and conventional aortic root replacement with a composite valve-conduit. Furthermore, these studies are limited by small patient numbers, selection bias.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Root Aneurysm, Aortic Root Dissection
Keywords
Valve sparing aortic root replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A(aortic valve sparing operation)
Arm Type
Active Comparator
Arm Description
Undergo aortic valve sparing root replacement operation
Arm Title
B(Bentall operation)
Arm Type
Active Comparator
Arm Description
Undergo Bentall operation
Intervention Type
Procedure
Intervention Name(s)
Aortic valve sparing operation
Intervention Description
Aortic valve sparing instead of replacement during aortic root replacement
Intervention Type
Procedure
Intervention Name(s)
Bentall operation
Intervention Description
Aortic root replacement with replacement of aortic valve
Primary Outcome Measure Information:
Title
Number of subjects who die
Description
Number of subjects who die either intraoperative or intrahospital
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Grade of aortic valve regurgitation
Description
Grade of postoperative aortic valve regurgitation by echocardiography
Time Frame
1,6 months and 1,2 years
Title
Mean gradient(mmgh) on the aortic valve
Description
Mean gradient(mmgh) on the aortic valve by echocardiography
Time Frame
1,2 years
Title
Thromboembolism/bleeding
Description
Number of subjects who present by Thromboembolism/bleeding
Time Frame
6 months and 1,2 years
Title
Prosthetic/native valve endocarditis
Description
Number of subjects who present with prosthetic/native valve endocarditis
Time Frame
6 months and 1,2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ascending aorta or aortic root aneurysm(size more than 5 cm or 4.5 cm in Marfan syndrome). Ascending aorta or aortic root dissection. With or without aortic regurgitation Good condition of aortic cusps. Exclusion Criteria: The left ventricular ejection fraction less than 40 %. Previous aortic valve replacement. Aortic stenosis. Patients with extensive aortic root destruction because of aortic root infection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa K Abd-Elnaim, Ass lecturer
Phone
0201008893237
Email
kamelmostafa843@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Ghoneim, Professor
Phone
0201001215565
Email
ahghoneim@aun.edu.eh
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A Nady, Lecturer
Organizational Affiliation
Assist university
Official's Role
Study Chair
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
15755
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mostafa K Abdelnaim
Phone
0201008893237
Email
Kamelmostafa843@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Citation
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Aortic Valve Sparing Root Replacement Versus Bentall

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