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Status unknownNCT05167539Updated Feb 7, 2022

Aortic Root Enlargement Versus Aortic Root Replacement in the Management of Cases With Small Aortic Root

An observational study in Aortic Valve Disease, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2022-02-07.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Sex
All
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Study summary

Each type of Aortic valve surgery has its advantages and disadvantages; we aim to differentiate between two types of aortic valve surgery: aortic root replacement (using either Ross procedure or stentless bioprosthesis procedure) and mechanical aortic valve replacement.

Read the detailed description

Aortic valve replacement has been performed since the 1950s. Since then, the surgical procedure has been optimized to reduce the risk of procedure-related complications. In addition, technical advances in the design of valves have significantly improved long-term prognosis. After the initial use of mechanical ball-caged valves, numerous monoleaflet and bileaflet valves have been introduced and evaluated. Moreover, bioprosthetic valves came on the market in the 1960s as an alternative to mechanical valve.

The pulmonary autograft was introduced in clinical practice as a substitute for the diseased aortic valve by Donald Ross in 1967. The original implant technique, namely subcoronary freehand grafting, was associated with substantial prevalence of early and late valve dysfunction, thereby limiting widespread adoption of the operation. More recent experience with pulmonary autografts used for complete or partial aortic root replacement allowed for satisfactory functional behavior of the valve .

Homografts for aortic valve replacement were the first biologic stentless prostheses used in clinical practice in the 1960s. Binet introduced a stentless porcine bioprosthesis, but the valve was abandoned because of poor tissue fixation. Due to limited availability and a relatively difficult implantation technique, mechanical AVR became the popular therapeutic option. The disadvantage of life-long anticoagulation therapy in mechanical AVR prompted the development of xenogeneic bioprostheses. Although porcine aortic valves or pericardial tissue mounted on a stent made the implantation technique easier, these valves sacrificed orifice area and increased stress at the attachment of the stent, which caused earlier primary tissue failure. Optimizing hemodynamics to prevent patient-prosthetic mismatch and improve durability revived the use of stentless bioprostheses in the early 1990s.

Patients with an expected survival of less than 10 years (more than 65 years old, renal disease, lung disease, patients who are more than 60 years old), ejection fraction of less than 40%, or coronary disease would be reasonable candidates for aortic bioprostheses to avoid anticoagulation with an extremely low likelihood of aortic valve reoperation. Results tend to favor mechanical aortic valves in patients under age 65 years with a life expectancy of at least 10 years.

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Conditions studied

  • Aortic Valve Disease

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03

In context

Aortic Valve Disease

231 studies on the registry are indexed under Aortic Valve Disease; 76 are open to participants now.

This study's planned enrollment of 100 is below the median of 200 across 112 observational studies indexed under Aortic Valve Disease.

Browse Aortic Valve Disease studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients who presented to Cardiothoracic Surgery Department, Assiut University Heart Hospital and Aswan heart center who meet the listed inclusion will be eligible for the study. The charts will be reviewed and eligible patients will be filtered

Inclusion criteria

  • Patients undergoing Aortic valve surgery.

Exclusion criteria

Exclusion Criteria:

  • Patients who have other procedure with aortic valve surgery.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Mechanical aortic valve replacement

    simple procedure but need long term of anticoagulant

    Procedure: Aortic valve surgery

  • Aortic root replacement

    complicated procedure but without anticoagulant

    Procedure: Aortic valve surgery

Interventions

  • ProcedureAortic valve surgery

    mechanical aortic valve replacement versus ross procedure and stentless bioprothesis

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What researchers measure

Primary outcomes

  1. Number of participants with failure of surgery

    Number of participants with failure of initial intervention , Requiring a second intervention i.e redo aortic valve surgery

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05167539
Lead sponsor
Assiut University
Responsible party
Ali Mohamed Abdelraouf (Assistant Lecturer, Assiut University) — Principal investigator
First posted
Dec 22, 2021
Start date
Feb 10, 2022 (estimated)
Primary completion
Feb 1, 2024 (estimated)
Completion
Feb 1, 2024 (estimated)
Last update
Feb 7, 2022

Study contacts

Ali Abdelraouf, Assistant lecturer
Contact
Aliabdelraouf92@yahoo.com
01004396639

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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