Aortic Valve Sparing Root Replacement Versus Bentall
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03604913 |
|
Recruitment Status :
Recruiting
First Posted : July 30, 2018
Last Update Posted : January 11, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
- Units of packed red blood cells.
B)secondary outcome measures:
- Grade of aortic valve regurgitation (0-4).
- Peak gradient on the aortic valve(mmHg).
- Thromboembolism / bleeding.
- Prosthetic/native valve endocarditis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Aortic Root Aneurysm Aortic Root Dissection | Procedure: Aortic valve sparing operation Procedure: Bentall operation | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Aortic Valve-sparing Root Replacement Operation Versus Bentall Operation - Early and Midterm Outcomes |
| Actual Study Start Date : | February 1, 2019 |
| Estimated Primary Completion Date : | September 1, 2022 |
| Estimated Study Completion Date : | October 1, 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: A(aortic valve sparing operation)
Undergo aortic valve sparing root replacement operation
|
Procedure: Aortic valve sparing operation
Aortic valve sparing instead of replacement during aortic root replacement |
|
Active Comparator: B(Bentall operation)
Undergo Bentall operation
|
Procedure: Bentall operation
Aortic root replacement with replacement of aortic valve |
- Number of subjects who die [ Time Frame: 14 days ]Number of subjects who die either intraoperative or intrahospital
- Grade of aortic valve regurgitation [ Time Frame: 1,6 months and 1,2 years ]Grade of postoperative aortic valve regurgitation by echocardiography
- Peak gradient(mmgh) on the aortic valve [ Time Frame: 6 months and 1,2 years ]Peak gradient(mmgh) on the aortic valve by echocardiography
- Thromboembolism/bleeding [ Time Frame: 6 months and 1,2 years ]Number of subjects who present by Thromboembolism/bleeding
- Prosthetic/native valve endocarditis [ Time Frame: 6 months and 1,2 years ]Number of subjects who present with prosthetic/native valve endocarditis
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
- Aortic regurgitation 2+.
- Good condition of aortic cusps.
Exclusion Criteria:
- The left ventricular ejection fraction less than 40 %.
- Aortic aneurysm or dissection without aortic regurgitation.
- Aortic stenosis.
- Patients with extensive aortic root destruction because of aortic root infection.
- Internal carotid artery stenosis more than 70%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604913
| Contact: Mostafa K Abd-Elnaim, Ass lecturer | 0201008893237 | kamelmostafa843@gmail.com | |
| Contact: Ahmed M Ghoneim, Professor | 0201001215565 | ahghoneim@aun.edu.eh |
| Egypt | |
| Assiut university | Recruiting |
| Assiut, Egypt, 15755 | |
| Contact: Mostafa K Abdelnaim 0201008893237 Kamelmostafa843@gmail.com | |
| Study Chair: | Mohamed A Nady, Lecturer | Assist university |
| Responsible Party: | Mostafa Kamel Abd-Elnaim Hussein, assistant lecturer, Assiut University |
| ClinicalTrials.gov Identifier: | NCT03604913 |
| Other Study ID Numbers: |
Valve sparing versus Bentall |
| First Posted: | July 30, 2018 Key Record Dates |
| Last Update Posted: | January 11, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Valve sparing aortic root replacement |
|
Aneurysm Vascular Diseases Cardiovascular Diseases |