Aortic Valve DiseaseAortic SurgeryNCT04277572
Outcomes of Surgery of Aortic Valve
An observational study of Aortic Valve Disease, run by Assiut University.
Trial summary
Overall Goal: To study the outcomes of patients undergoing aortic valve surgeries, different approaches such as standard aortic valve replacement, aortic valve repair, novel techniques as Ozaki's procedure and their subsequent results and complications. 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 replacement
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 31 Dec 2022
- 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 registered in cardiac surgery department database, and who meet the listed inclusion and exclusion criteria will be eligible for the study.
Who may be able to join
- Patients with severe symptomatic aortic valve lesion.
- Asymptomatic aortic insufficiency patients with left ventricular dysfunction or significant left ventricular dilatation (LV end diastolic diameter>70 mm or LV end systolic diameter>50 mm.
- Patients with aortic regurgitation caused by:
- a dilated aortic annulus
- conjoined cusp prolapse in bicuspid aortic valves (BAV)
- single cusp prolapse in tricuspid aortic valves
- aortic valve cusp perforation from endocarditis
Who cannot join
- Patients with previous aortic root or valve surgery.
About this study
Official title: Outcomes of Different Modalities for Surgery of Aortic Valve
Overall Goal: To study the outcomes of patients undergoing aortic valve surgeries, different approaches such as standard aortic valve replacement, aortic valve repair, novel techniques as Ozaki's procedure and their subsequent results and complications.
- Objective 1: Identify predictors of complications following different types of aortic valve surgery accordingly.
- Objective 2: Determine the value of each type in terms of advantages and disadvantages.
- Objective3: Assess outcomes such as postoperative life expectancy, hospital stay, prognosis and quality of life.
- Conditions
- Aortic Valve Disease
- Being tested
- Aortic valve replacement
- 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 replacementProcedure or surgery
Also called Ozaki procedure
Aortic valve surgery
| Study group | Role | What they receive |
|---|---|---|
| Aortic valve replacement | using different ways of aortic valve replacement either by prosthetic valves or by ozaki technique Receives: Procedure: Aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcomes of different techniques of aortic valve surgery in the indicated patients for each type of surgery such as :
Number of days of postoperative hospital stay.
Measured: Up to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gamal Thabet Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277572
- Sponsor's protocol ID
- 17200395
- Acronym
- Aortic Surgery
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Different Modalities for Surgery of Aortic Valve
- ClinicalTrials.gov ID
- NCT04277572
- Acronym / sponsor ID
- Aortic Surgery / 17200395
- Conditions
- Aortic Valve Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Feb 2020 (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.
Overall Goal: To study the outcomes of patients undergoing aortic valve surgeries, different approaches such as standard aortic valve replacement, aortic valve repair, novel techniques as Ozaki's procedure and their subsequent results and complications.
- Objective 1: Identify predictors of complications following different types of aortic valve surgery accordingly.
- Objective 2: Determine the value of each type in terms of advantages and disadvantages.
- Objective3: Assess outcomes such as postoperative life expectancy, hospital stay, prognosis and quality of life.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortic valve replacement | – | Procedure: Aortic valve replacementusing different ways of aortic valve replacement either by prosthetic valves or by ozaki technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients registered in cardiac surgery department database, and who meet the listed inclusion and exclusion criteria will be eligible for the study.
Key inclusion criteria (7 listed)
- Patients with severe symptomatic aortic valve lesion.
- Asymptomatic aortic insufficiency patients with left ventricular dysfunction or significant left ventricular dilatation (LV end diastolic diameter>70 mm or LV end systolic diameter>50 mm.
- Patients with aortic regurgitation caused by:
Key exclusion criteria (1 listed)
- Patients with previous aortic root or valve surgery.
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 replacementAlso: Ozaki procedureAortic valve surgery | Procedure or surgery | Aortic valve replacement |
Primary outcome
Outcomes of different techniques of aortic valve surgery in the indicated patients for each type of surgery such as :
Time frame: Up to one week
Number of days of postoperative hospital stay.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 7 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 20 Feb 2020. 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?
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?
Outcomes of different techniques of aortic valve surgery in the indicated patients for each type of surgery such as : (time frame: Up to one week). 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 20 Feb 2020.