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Aortic Valve DiseaseNCT05167539

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

An observational study of Aortic Valve Disease, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Any age
Conditions the study is for
Aortic Valve Disease
What is being tested?
Aortic valve surgery
Type of treatment
Surgery or procedure
How many people
100 participants
Where
No sites listed yet
Study dates
10 Feb 2022to 1 Feb 2024
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • Patients undergoing Aortic valve surgery.

Who cannot join

  • Patients who have other procedure with aortic valve surgery.

Trial locations and contacts

No sites are listed yet.

Ali Abdelraouf, Assistant lecturer contact

01004396639

Aliabdelraouf92@yahoo.com

About this study

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.

Being tested
Aortic valve surgery
Medical subject headings
Aortic Valve Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aortic valve surgeryProcedure or surgery

    mechanical aortic valve replacement versus ross procedure and stentless bioprothesis

Study groups in NCT05167539
Study groupRoleWhat they receive
Mechanical aortic valve replacementsimple procedure but need long term of anticoagulant
Receives: Procedure: Aortic valve surgery
Aortic root replacementcomplicated procedure but without anticoagulant
Receives: Procedure: Aortic valve surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2021
  2. Study start10 Feb 2022 (estimated)
  3. Primary completion1 Feb 2024 (estimated)
  4. Study completion1 Feb 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05167539
Sponsor's protocol ID
Aortic valve surgery
Status last verified
Jan 2022
First submitted
20 Dec 2021
Last updated
7 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Valve Disease, run by Assiut University.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ali Abdelraouf, Assistant lecturer (01004396639, Aliabdelraouf92@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with failure of surgery (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Feb 2022.

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