Aortic Root AneurysmNCT03604913
Aortic Valve Sparing Root Replacement Versus Bentall
A study testing Aortic valve sparing operation and Bentall operation in people with Aortic Root Aneurysm and Aortic Root Dissection, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aortic Root Aneurysm, Aortic Root Dissection
- What is being tested?
- Aortic valve sparing operation and Bentall operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aortic Valve-sparing Root Replacement Operation Versus Bentall Operation - Early and Midterm Outcomes
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:
Read more
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:
- 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
Read the 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.
- Conditions
- Aortic Root Aneurysm, Aortic Root Dissection
- Being tested
- Aortic valve sparing operation, Bentall operation
- Keywords
- Valve sparing aortic root replacement
- Medical subject headings
- Aortic Root Aneurysm, Dissection, Ascending Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic valve sparing operationProcedure or surgery
Aortic valve sparing instead of replacement during aortic root replacement
Bentall operationProcedure or surgery
Aortic root replacement with replacement of aortic valve
| Study group | Role | What they receive |
|---|---|---|
| A(aortic valve sparing operation) | Active comparator | Undergo aortic valve sparing root replacement operation Receives: Procedure: Aortic valve sparing operation |
| B(Bentall operation) | Active comparator | Undergo Bentall operation Receives: Procedure: Bentall operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects who die
Number of subjects who die either intraoperative or intrahospital
Measured: 30 days
Secondary outcomes (4)
Grade of aortic valve regurgitation
Grade of postoperative aortic valve regurgitation by echocardiography
Measured: 1,6 months and 1,2 years
Mean gradient(mmgh) on the aortic valve
Mean gradient(mmgh) on the aortic valve by echocardiography
Measured: 1,2 years
Thromboembolism/bleeding
Number of subjects who present by Thromboembolism/bleeding
Measured: 6 months and 1,2 years
Prosthetic/native valve endocarditis
Number of subjects who present with prosthetic/native valve endocarditis
Measured: 6 months and 1,2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Feb 2019
- Primary completion27 Feb 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Aortic Root AneurysmStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Kamel Abd-Elnaim Hussein, Assiut University
- Investigators
- Mohamed A Nady, Lecturer, Study chair, Assist university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604913
- Sponsor's protocol ID
- Valve sparing versus Bentall
- Status last verified
- Feb 2025
- First submitted
- 12 Jul 2018
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Majumder PP, St Jean PL, Ferrell RE, Webster MW, Steed DL. On the inheritance of abdominal aortic aneurysm. Am J Hum Genet. 1991 Jan;48(1):164-70.
PubMed 1985458Gillum RF. Epidemiology of aortic aneurysm in the United States. J Clin Epidemiol. 1995 Nov;48(11):1289-98. doi: 10.1016/0895-4356(95)00045-3.
PubMed 7490591De Paulis R, Bassano C, Bertoldo F, Chiariello L. Aortic valve-sparing operations and aortic root replacement. J Cardiovasc Med (Hagerstown). 2007 Feb;8(2):97-101. doi: 10.2459/01.JCM.0000260209.73097.f4.
PubMed 17299290Bentall H, De Bono A. A technique for complete replacement of the ascending aorta. Thorax. 1968 Jul;23(4):338-9. doi: 10.1136/thx.23.4.338.
PubMed 5664694Zehr KJ, Orszulak TA, Mullany CJ, Matloobi A, Daly RC, Dearani JA, Sundt TM 3rd, Puga FJ, Danielson GK, Schaff HV. Surgery for aneurysms of the aortic root: a 30-year experience. Circulation. 2004 Sep 14;110(11):1364-71. doi: 10.1161/01.CIR.0000141593.05085.87. Epub 2004 Aug 16.
PubMed 15313937Mataraci I, Polat A, Kiran B, Caliskan A, Tuncer A, Erentug V, Kirali K, Isik O, Yakut C. Long-term results of aortic root replacement: 15 years' experience. Ann Thorac Surg. 2009 Jun;87(6):1783-8. doi: 10.1016/j.athoracsur.2009.03.046.
PubMed 19463595Etz CD, Bischoff MS, Bodian C, Roder F, Brenner R, Griepp RB, Di Luozzo G. The Bentall procedure: is it the gold standard? A series of 597 consecutive cases. J Thorac Cardiovasc Surg. 2010 Dec;140(6 Suppl):S64-70; discussion S86-91. doi: 10.1016/j.jtcvs.2010.07.033.
PubMed 21092800Kouchoukos NT, Wareing TH, Murphy SF, Perrillo JB. Sixteen-year experience with aortic root replacement. Results of 172 operations. Ann Surg. 1991 Sep;214(3):308-18; discussion 318-20. doi: 10.1097/00000658-199109000-00013.
PubMed 1834031Sarsam MA, Yacoub M. Remodeling of the aortic valve anulus. J Thorac Cardiovasc Surg. 1993 Mar;105(3):435-8.
PubMed 8445922David TE, Feindel CM. An aortic valve-sparing operation for patients with aortic incompetence and aneurysm of the ascending aorta. J Thorac Cardiovasc Surg. 1992 Apr;103(4):617-21; discussion 622.
PubMed 1532219Gaudino M, Lau C, Munjal M, Avgerinos D, Girardi LN. Contemporary outcomes of surgery for aortic root aneurysms: A propensity-matched comparison of valve-sparing and composite valve graft replacement. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1120-9.e1. doi: 10.1016/j.jtcvs.2015.07.015. Epub 2015 Jul 10.
PubMed 26234456Coselli JS, Volguina IV, LeMaire SA, Sundt TM, Connolly HM, Stephens EH, Schaff HV, Milewicz DM, Vricella LA, Dietz HC, Minard CG, Miller DC; Aortic Valve Operative Outcomes in Marfan Patients Study Group. Early and 1-year outcomes of aortic root surgery in patients with Marfan syndrome: a prospective, multicenter, comparative study. J Thorac Cardiovasc Surg. 2014 Jun;147(6):1758-66, 1767.e1-4. doi: 10.1016/j.jtcvs.2014.02.021. Epub 2014 Feb 8.
PubMed 24655904Toeg H, Chan V, Rao RV, Chan KL, Ruel M, Mesana T, Boodhwani M. Contemporary midterm echocardiographic outcomes of Bentall procedure and aortic valve sparing root replacement. Ann Thorac Surg. 2014 Aug;98(2):590-6. doi: 10.1016/j.athoracsur.2014.04.121. Epub 2014 Jun 24.
PubMed 24968770Tourmousoglou C, Rokkas C. Is aortic valve-sparing operation or replacement with a composite graft the best option for aortic root and ascending aortic aneurysm? Interact Cardiovasc Thorac Surg. 2009 Jan;8(1):134-47. doi: 10.1510/icvts.2008.186544. Epub 2008 Oct 21.
PubMed 18940830Lim JY, Kim JB, Jung SH, Choo SJ, Chung CH, Lee JW. Surgical Management of Aortic Root Dilatation with Advanced Aortic Regurgitation: Bentall Operation versus Valve-sparing Procedure. Korean J Thorac Cardiovasc Surg. 2012 Jun;45(3):141-7. doi: 10.5090/kjtcs.2012.45.3.141. Epub 2012 Jun 7.
PubMed 22708080
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Valve-sparing Root Replacement Operation Versus Bentall Operation - Early and Midterm Outcomes
- ClinicalTrials.gov ID
- NCT03604913
- Acronym / sponsor ID
- Valve sparing versus Bentall
- Conditions
- Aortic Root Aneurysm, Aortic Root Dissection
- Keywords
- Valve sparing aortic root replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A(aortic valve sparing operation) | Active comparator | Procedure: Aortic valve sparing operationUndergo aortic valve sparing root replacement operation |
| B(Bentall operation) | Active comparator | Procedure: Bentall operationUndergo Bentall operation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aortic valve sparing operationAortic valve sparing instead of replacement during aortic root replacement | Procedure or surgery | A(aortic valve sparing operation) |
| Bentall operationAortic root replacement with replacement of aortic valve | Procedure or surgery | B(Bentall operation) |
Primary outcome
Number of subjects who die
Time frame: 30 days
Number of subjects who die either intraoperative or intrahospital
4 secondary outcomes
Grade of aortic valve regurgitation
Time frame: 1,6 months and 1,2 years
Mean gradient(mmgh) on the aortic valve
Time frame: 1,2 years
Thromboembolism/bleeding
Time frame: 6 months and 1,2 years
Prosthetic/native valve endocarditis
Time frame: 6 months and 1,2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Background: PubMed 1985458Majumder PP, St Jean PL, Ferrell RE, Webster MW, Steed DL. On the inheritance of abdominal aortic aneurysm. Am J Hum Genet. 1991 Jan;48(1):164-70.
- Background: PubMed 7490591Gillum RF. Epidemiology of aortic aneurysm in the United States. J Clin Epidemiol. 1995 Nov;48(11):1289-98. doi: 10.1016/0895-4356(95)00045-3.
- Background: PubMed 17299290De Paulis R, Bassano C, Bertoldo F, Chiariello L. Aortic valve-sparing operations and aortic root replacement. J Cardiovasc Med (Hagerstown). 2007 Feb;8(2):97-101. doi: 10.2459/01.JCM.0000260209.73097.f4.
- Background: PubMed 5664694Bentall H, De Bono A. A technique for complete replacement of the ascending aorta. Thorax. 1968 Jul;23(4):338-9. doi: 10.1136/thx.23.4.338.
- Background: PubMed 15313937Zehr KJ, Orszulak TA, Mullany CJ, Matloobi A, Daly RC, Dearani JA, Sundt TM 3rd, Puga FJ, Danielson GK, Schaff HV. Surgery for aneurysms of the aortic root: a 30-year experience. Circulation. 2004 Sep 14;110(11):1364-71. doi: 10.1161/01.CIR.0000141593.05085.87. Epub 2004 Aug 16.
- Background: PubMed 19463595Mataraci I, Polat A, Kiran B, Caliskan A, Tuncer A, Erentug V, Kirali K, Isik O, Yakut C. Long-term results of aortic root replacement: 15 years' experience. Ann Thorac Surg. 2009 Jun;87(6):1783-8. doi: 10.1016/j.athoracsur.2009.03.046.
- Background: PubMed 21092800Etz CD, Bischoff MS, Bodian C, Roder F, Brenner R, Griepp RB, Di Luozzo G. The Bentall procedure: is it the gold standard? A series of 597 consecutive cases. J Thorac Cardiovasc Surg. 2010 Dec;140(6 Suppl):S64-70; discussion S86-91. doi: 10.1016/j.jtcvs.2010.07.033.
- Background: PubMed 1834031Kouchoukos NT, Wareing TH, Murphy SF, Perrillo JB. Sixteen-year experience with aortic root replacement. Results of 172 operations. Ann Surg. 1991 Sep;214(3):308-18; discussion 318-20. doi: 10.1097/00000658-199109000-00013.
- Background: PubMed 8445922Sarsam MA, Yacoub M. Remodeling of the aortic valve anulus. J Thorac Cardiovasc Surg. 1993 Mar;105(3):435-8.
- Background: PubMed 1532219David TE, Feindel CM. An aortic valve-sparing operation for patients with aortic incompetence and aneurysm of the ascending aorta. J Thorac Cardiovasc Surg. 1992 Apr;103(4):617-21; discussion 622.
- Background: PubMed 26234456Gaudino M, Lau C, Munjal M, Avgerinos D, Girardi LN. Contemporary outcomes of surgery for aortic root aneurysms: A propensity-matched comparison of valve-sparing and composite valve graft replacement. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1120-9.e1. doi: 10.1016/j.jtcvs.2015.07.015. Epub 2015 Jul 10.
- Background: PubMed 24655904Coselli JS, Volguina IV, LeMaire SA, Sundt TM, Connolly HM, Stephens EH, Schaff HV, Milewicz DM, Vricella LA, Dietz HC, Minard CG, Miller DC; Aortic Valve Operative Outcomes in Marfan Patients Study Group. Early and 1-year outcomes of aortic root surgery in patients with Marfan syndrome: a prospective, multicenter, comparative study. J Thorac Cardiovasc Surg. 2014 Jun;147(6):1758-66, 1767.e1-4. doi: 10.1016/j.jtcvs.2014.02.021. Epub 2014 Feb 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed A Nady, Lecturer study chair
Assist university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aortic valve sparing operation and Bentall operation in people with Aortic Root Aneurysm and Aortic Root Dissection, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects who die (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03604913, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.