Aortic Valve ReplacementNCT03603483
Aortic Root Enlargement in Aortic Valve Replacement
A study testing procedure in people with Aortic Valve Replacement, run by Assiut University.
Trial summary
Aortic valve disease is a progressive illness that varies from minor valve thickening lacking obstruction of blood stream to severe calcification and alteration of the valve leading to weakened leaflet motion. Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- Aortic Valve Replacement
- What is being tested?
- procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2019to 30 Mar 2019
- 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 17 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 17-75 years old
- patients with sever aortic valve stenosis undergoing valve replacement surgery
- informed consent has been obtained
Who cannot join
- Planned off-pump cardiac surgery
- Patients required intra-aortic balloon pump
- under 17 years of age
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Short Term Outcome of Aortic Root Enlargement in Management of Small Aortic Annulus Among Patients With Severe Valvular Aortic Stenosis
Aortic valve disease is a progressive illness that varies from minor valve thickening lacking obstruction of blood stream to severe calcification and alteration of the valve leading to weakened leaflet motion. Aortic valve replacement is a usual operation but can be complicated by a small aortic annulus requiring the insertion of an aortic valve prosthesis. Prosthesis-patient discrepancy results in worse outcomes.
Read the detailed description
Prosthesis-patient discrepancy results in worse outcomes, including elevated left ventricular work, decreased left ventricular mass regression, and has also been linked with high mortality. Therefore, Aortic root posterior enlargement by autologous fixed pericardium to insert an Aortic valve prosthesis with size suitable to patient body surface area to avoid the previous worse outcome of patient prosthesis mismatch. In this study the investigators will try to identify the benefits of Aortic Root Enlargement in management of Small Aortic Annulus in Patients with severe valvular aortic stenosis
- Conditions
- Aortic Valve Replacement
- Being tested
- procedure
- Keywords
- patients- prosthesis mismatching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procedureProcedure or surgery
Patients of sever aortic stenosis 1: increase the diameter of aortic anulus by prosthetic patch or pericardial patch.
Patients of sever aortic stenosis 1:only conventional aortic valve prosthesis will be used
| Study group | Role | What they receive |
|---|---|---|
| Patients with sever aortic stenosis 1 | Active comparator | Procedure: the patients will undergo aortic valve replacement with aortic root enlargement. Receives: Procedure: procedure |
| Patients with sever aortic stenosis 2 | Active comparator | Procedure: the patients will undergo conventional aortic valve replacement Receives: Procedure: procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transthoracic echocardiographic measurement of transvalvular gradient across aortic valve prosthesis<25 mmHg
Mild stenosis gradient 25 mmHg, Moderate stenosis gradient 25-40 mmHg, Sever stenosis gradient >40 mmHg
Measured: Baseline 6 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start15 Jan 2019 (estimated)
- Primary completion28 Mar 2019 (estimated)
- Study completion30 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve ReplacementStudies 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
- Model description
- Aortic Root Enlargement in Patients with aortic stenosis with Small Aortic Annulus
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed mahmoud ahmed, Assiut University
- Investigators
- Mohamed mahmoud ahmed, Doctor, Principal investigator, Lecturer of cardiothoracic surgery, Faculty of Medicine, Assiut University, Assiut, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603483
- Sponsor's protocol ID
- Aortic root enlargement
- Status last verified
- Jan 2019
- First submitted
- 8 Mar 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dumani S, Likaj E, Dibra L, Llazo S, Refatllari A. Aortic Annular Enlargement during Aortic Valve Replacement. Open Access Maced J Med Sci. 2016 Sep 15;4(3):455-457. doi: 10.3889/oamjms.2016.098. Epub 2016 Sep 2.
PubMed 27703574Rocha RV, Manlhiot C, Feindel CM, Yau TM, Mueller B, David TE, Ouzounian M. Surgical Enlargement of the Aortic Root Does Not Increase the Operative Risk of Aortic Valve Replacement. Circulation. 2018 Apr 10;137(15):1585-1594. doi: 10.1161/CIRCULATIONAHA.117.030525. Epub 2017 Nov 22.
PubMed 29167226
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Outcome of Aortic Root Enlargement in Management of Small Aortic Annulus Among Patients With Severe Valvular Aortic Stenosis
- ClinicalTrials.gov ID
- NCT03603483
- Acronym / sponsor ID
- Aortic root enlargement
- Conditions
- Aortic Valve Replacement
- Keywords
- patients- prosthesis mismatching
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (estimated)
- Primary completion
- 28 Mar 2019 (estimated)
- Study completion
- 30 Mar 2019 (estimated)
- First posted
- 27 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.
Aortic valve disease is a progressive illness that varies from minor valve thickening lacking obstruction of blood stream to severe calcification and alteration of the valve leading to weakened leaflet motion. Aortic valve replacement is a usual operation but can be complicated by a small aortic annulus requiring the insertion of an aortic valve prosthesis. Prosthesis-patient discrepancy results in worse outcomes.
Detailed description
Prosthesis-patient discrepancy results in worse outcomes, including elevated left ventricular work, decreased left ventricular mass regression, and has also been linked with high mortality. Therefore, Aortic root posterior enlargement by autologous fixed pericardium to insert an Aortic valve prosthesis with size suitable to patient body surface area to avoid the previous worse outcome of patient prosthesis mismatch. In this study the investigators will try to identify the benefits of Aortic Root Enlargement in management of Small Aortic Annulus in Patients with severe valvular aortic stenosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Aortic Root Enlargement in Patients with aortic stenosis with Small Aortic Annulus
| Arm | Type | Receives |
|---|---|---|
| Patients with sever aortic stenosis 1 | Active comparator | Procedure: procedureProcedure: the patients will undergo aortic valve replacement with aortic root enlargement. |
| Patients with sever aortic stenosis 2 | Active comparator | Procedure: procedureProcedure: the patients will undergo conventional aortic valve replacement |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 17-75 years old
- patients with sever aortic valve stenosis undergoing valve replacement surgery
- informed consent has been obtained
Key exclusion criteria (3 listed)
- Planned off-pump cardiac surgery
- Patients required intra-aortic balloon pump
- under 17 years of age
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 |
|---|---|---|
| procedurePatients of sever aortic stenosis 1: increase the diameter of aortic anulus by prosthetic patch or pericardial patch. Patients of sever aortic stenosis 1:only conventional aortic valve prosthesis will be used | Procedure or surgery | Patients with sever aortic stenosis 1, Patients with sever aortic stenosis 2 |
Primary outcome
Transthoracic echocardiographic measurement of transvalvular gradient across aortic valve prosthesis<25 mmHg
Time frame: Baseline 6 weeks postoperative
Mild stenosis gradient 25 mmHg, Moderate stenosis gradient 25-40 mmHg, Sever stenosis gradient >40 mmHg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Background: PubMed 27703574Dumani S, Likaj E, Dibra L, Llazo S, Refatllari A. Aortic Annular Enlargement during Aortic Valve Replacement. Open Access Maced J Med Sci. 2016 Sep 15;4(3):455-457. doi: 10.3889/oamjms.2016.098. Epub 2016 Sep 2.
- Background: PubMed 29167226Rocha RV, Manlhiot C, Feindel CM, Yau TM, Mueller B, David TE, Ouzounian M. Surgical Enlargement of the Aortic Root Does Not Increase the Operative Risk of Aortic Valve Replacement. Circulation. 2018 Apr 10;137(15):1585-1594. doi: 10.1161/CIRCULATIONAHA.117.030525. Epub 2017 Nov 22.
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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 mahmoud ahmed, Doctor principal investigator
Lecturer of cardiothoracic surgery, Faculty of Medicine, Assiut University, Assiut, Egypt
Questions about this trial
What is this clinical trial studying?
A study testing procedure in people with Aortic Valve Replacement, 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 3 inclusion and 3 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 9 Jan 2019. 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 Mohamed mahmoud ahmed, Doctor (01008332462, mohamedmahmoudclinic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transthoracic echocardiographic measurement of transvalvular gradient across aortic valve prosthesis<25 mmHg (time frame: Baseline 6 weeks postoperative). 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 NCT03603483, which also lists 2 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 9 Jan 2019.