Severe Aortic StenosisNCT06834828
Prevalence of Cusp Asymmetry, Coronary Ostial Eccentricity in Patients Undergoing Trans Catheter Aortic Valve Implantation and Their Impact on Coronary Ostia Overlap Risk Assessment
An observational study of Severe Aortic Stenosis and Trans-catheter Aortic Valve Implantation, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this observational study is to measure the prevalence of Cusps asymmetry, coronary Ostial eccentricity in patients with severe aortic stenosis undergoing Trans-catheter Aortic Valve Implantation (TAVI) and measure the degree of coronary ostia overlap with trans-catheter neo-commissure. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Severe Aortic Stenosis, Trans-catheter Aortic Valve Implantation, Coronary Ostial Eccentricity
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Jan 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - Severe Aortic stenosis with tri-leaflets aortic valve undergoing Trans catheter Aortic valve Implantation
Who may be able to join
- Severe Aortic stenosis with tri-leaflets aortic valve undergoing Trans catheter Aortic valve Implantation
Who cannot join
- severe Aortic stenosis with bicuspid leaflets aortic valve
- severe Aortic stenosis undergoing surgical aortic valve replacement
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Ain Shams University
Abbasia, Cairo Governorate, 11517
About this study
Official title: Prevalence of Cusp Asymmetry , Coronary Ostial Eccentricity in Patients Undergoing Trans Catheter Aortic Valve Implantation and Their Impact on Coronary Ostial OverlaP Risk Assessment: an Egyptian CO-OPRA Cohort Study
The goal of this observational study is to measure the prevalence of Cusps asymmetry, coronary Ostial eccentricity in patients with severe aortic stenosis undergoing Trans-catheter Aortic Valve Implantation (TAVI) and measure the degree of coronary ostia overlap with trans-catheter neo-commissure. The main question it aims to answer is:
Do coronary ostial eccentricity or cusp asymmetry have impact on coronary ostia overlap with trans-catheter neo-commissure? Participants already taking TAVI as part of their regular medical care for severe symptomatic aortic stenosis will do post procedural ECG-gated non contrast Multi-detector Computed Tomographic Angiography (MDCTA).
Read the detailed description
All patients will be subjected to:
Pre-procedural data:
- Proper history taking including:
- Age.
- Sex
- Body weight, height, and calculated body mass index
- Previous related medical history (Hypertensive, Diabetic, Rheumatic heart disease, Peripheral vascular disease, Cerebrovascular disease, Chronic kidney disease, Chronic lung disease.)
- Previous coronary artery disease (completely revascularized or non-revascularized)
- Previous related surgical history (Surgical valve replacement, Coronary artery bypass graft surgery (CABG) or PCI, Peripheral vascular stenting or bypass graft surgery and carotid stenting or endarterectomy).
- 12-lead surface electrocardiogram (ECG):
- Intrinsic rhythm.
- PR interval duration.
- QRS duration.
- Presence or absence of bundle branch block.
- Baseline ischemic ECG changes (Q waves, ST segment depression or elevation and T wave inverted or flat).
- Transthoracic echocardiography:
- Left Ventricular (LV) internal dimensions (end diastolic and end systolic)
- LV wall thickness and symmetricity (septum and posterior wall)
- LV ejection fraction by M- mode and 2D eye balling.
- Resting segmental LV wall motion abnormality.
- Peak and mean pressure gradient across AV.
- AV area using continuity.
- AV leaflets number (tricuspid or bicuspid), thickening and degree of calcification.
- Presence or absence and degree of Aortic regurgitation (AR).
- Mitral valve annulus calcification.
- Presence or absence of Mitral valve regurgitation.
- Multi-detector Computed Tomographic Angiography (MDCTA) using pre-TAVI protocol:
Pre-procedural contrast enhanced MD cardiac CT imaging will be performed in all patients, Image acquisition will be performed with electrocardiographic gating. All CT data will be reconstructed using images in systolic phase (25-35%) intervals throughout the cardiac cycle with a slice thickness and a slice increment of 0.5 mm and will be analyzed using Osirix viewer software.
All the following parameter and data will be collected pre-procedural:
- Calcium score of aortic annulus and degree of valve calcification and calcium distribution
- LV outflow tract (LVOT) calcification
- Aortic annulus (mean diameters, area derived diameter, perimeter derived diameter)
- Diameter of sinus of Valsalva.
- Height of coronary ostia.
- Assessment of coronary arteries (calcification, degree of plaque causing stenosis, plaque type, presence of previously deployed stents regarding site and their patency if feasible, and the need for pre-TAVI invasive selective coronary angiography with or without PCI).
- Assessment of arterial access (minimal lumen diameter, tortuosity, and calcium distribution).
- Assessment of cusp symmetry:
After identifying the aortic annulus on cardiac CT imaging, a parallel plane few millimeters above the aortic annulus, where all 3 commissures are clearly visible, will be used to evaluate cusp symmetry.
The angle between both commissures of each cusp will be measured and the largest cusp will be identified and classified into 4 categories according to the angle of the largest cusp.
- Symmetric (120°-125°)
- Mildly asymmetric (125°-130°)
- Moderately asymmetric (130°-135°)
- Severely asymmetric (> 135°). - Assessment of Coronary ostia eccentricity:
Based on the angle deviation between each coronary ostium and the bisector of the corresponding cusp, the eccentricity of coronary ostia will be classified as:
- Centered (0°-10°).
- Mildly eccentric (10-20°).
- Moderately eccentric (20°-30°).
- Severely eccentric (>30°)
- Coplanar view by using nadir of each cusp at level of annulus.
- Cusp Overlap view by overlapping nadirs of right coronary cusp (RCC) and left coronary cusp (LCC)
- Coronary ostia overlap view using coronary ostium of right coronary artery (RCA) and left coronary artery (LCA) instead of the nadirs of RCC and LCC respectively also at level of annulus, then measuring the difference between two angles in LAO/RAO and Cranial /caudal projection.
- The angular difference between the right/left cusp and coronary ostia overlap view will be calculated by subtracting the latter fluoroscopic angulation from the prior angulation in both right anterior oblique (RAO)/left anterior oblique (RAO/LAO) and caudal/cranial coordinates. Scatterplots will be composed with RAO/LAO angles at the x-axis and cranial/caudal angles at the y-axis, to show the spatial distribution of both fluoroscopic views and to illustrate the intra-patient fluoroscopic angular difference for every patient.
Post-procedural data:
- 12-lead surface electrocardiogram (ECG) immediate post procedure and pre discharge:
- Intrinsic rhythm.
- PR interval duration.
- QRS duration.
- Presence or absence of bundle branch block.
- Changes indicating ongoing myocardial ischemia (Q waves, ST segment depression or elevation and T wave inverted or flat).
- Transthoracic echocardiography immediate post procedure and pre-discharge:
- LV ejection fraction by M- mode and 2D eye balling.
- Resting segmental LV wall motion abnormality.
- Peak and mean pressure gradient across implanted AV.
- Presence of pericardial effusion.
- Presence of paravalvular leakage (PVL) and PVL degree.
- ECG gated MDCT post TAVI:
Post-procedural non contrast enhanced MD cardiac CT imaging will be performed in all patients; Image acquisition will be performed with electrocardiographic gating. All CT data will be reconstructed using images in systolic phase (25-35%) intervals throughout the cardiac cycle with a slice thickness and a slice increment of 0.5 mm and will be analyzed using Osirix viewer software.
Based on identification of neo-commissures by commissural markers (CM) (i.e. commissural posts in Acurate neo 2 and C tap in Evolut R /Pro) assessment of coronary overlap (CO) and commissural misalignment (CMA) can be possible as following:
- Coronary overlap (CO): By measuring the angle between each coronary ostium (RCA and LCA) and nearest neo-commissure and categorize CO into 3 groups
- Severe overlap when < 20°.
- Moderate overlap when 20-35°.
- Optimal overlap when > 35°.
- Conditions
- Severe Aortic Stenosis, Trans-catheter Aortic Valve Implantation, Coronary Ostial Eccentricity
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Severe Aortic stenosis patients underwent trans catheter Aortic valve Implantation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Ostia Overlap with neo-commissures
Measuring angle between trans catheter Aortic valve neo-commissures and coronary Ostia
Measured: With in 30 days from indexed procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Jun 2023
- Primary completion1 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834828
- Sponsor's protocol ID
- FMASU MD140/2023
- Status last verified
- Jul 2023
- First submitted
- 14 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: share individual participant data may requires participant approval
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
- Prevalence of Cusp Asymmetry , Coronary Ostial Eccentricity in Patients Undergoing Trans Catheter Aortic Valve Implantation and Their Impact on Coronary Ostial OverlaP Risk Assessment: an Egyptian CO-OPRA Cohort Study
- ClinicalTrials.gov ID
- NCT06834828
- Acronym / sponsor ID
- FMASU MD140/2023
- Conditions
- Severe Aortic Stenosis, Trans-catheter Aortic Valve Implantation, Coronary Ostial Eccentricity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 19 Feb 2025 (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.
The goal of this observational study is to measure the prevalence of Cusps asymmetry, coronary Ostial eccentricity in patients with severe aortic stenosis undergoing Trans-catheter Aortic Valve Implantation (TAVI) and measure the degree of coronary ostia overlap with trans-catheter neo-commissure. The main question it aims to answer is:
Do coronary ostial eccentricity or cusp asymmetry have impact on coronary ostia overlap with trans-catheter neo-commissure? Participants already taking TAVI as part of their regular medical care for severe symptomatic aortic stenosis will do post procedural ECG-gated non contrast Multi-detector Computed Tomographic Angiography (MDCTA).
Detailed description
All patients will be subjected to:
Pre-procedural data:
- Proper history taking including:
- Age.
- Sex
- Body weight, height, and calculated body mass index
- Previous related medical history (Hypertensive, Diabetic, Rheumatic heart disease, Peripheral vascular disease, Cerebrovascular disease, Chronic kidney disease, Chronic lung disease.)
- Previous coronary artery disease (completely revascularized or non-revascularized)
- Previous related surgical history (Surgical valve replacement, Coronary artery bypass graft surgery (CABG) or PCI, Peripheral vascular stenting or bypass graft surgery and carotid stenting or endarterectomy).
- 12-lead surface electrocardiogram (ECG):
- Intrinsic rhythm.
- PR interval duration.
- QRS duration.
- Presence or absence of bundle branch block.
- Baseline ischemic ECG changes (Q waves, ST segment depression or elevation and T wave inverted or flat).
- Transthoracic echocardiography:
- Left Ventricular (LV) internal dimensions (end diastolic and end systolic)
- LV wall thickness and symmetricity (septum and posterior wall)
- LV ejection fraction by M- mode and 2D eye balling.
- Resting segmental LV wall motion abnormality.
- Peak and mean pressure gradient across AV.
- AV area using continuity.
- AV leaflets number (tricuspid or bicuspid), thickening and degree of calcification.
- Presence or absence and degree of Aortic regurgitation (AR).
- Mitral valve annulus calcification.
- Presence or absence of Mitral valve regurgitation.
- Multi-detector Computed Tomographic Angiography (MDCTA) using pre-TAVI protocol:
Pre-procedural contrast enhanced MD cardiac CT imaging will be performed in all patients, Image acquisition will be performed with electrocardiographic gating. All CT data will be reconstructed using images in systolic phase (25-35%) intervals throughout the cardiac cycle with a slice thickness and a slice increment of 0.5 mm and will be analyzed using Osirix viewer software.
All the following parameter and data will be collected pre-procedural:
- Calcium score of aortic annulus and degree of valve calcification and calcium distribution
- LV outflow tract (LVOT) calcification
- Aortic annulus (mean diameters, area derived diameter, perimeter derived diameter)
- Diameter of sinus of Valsalva.
- Height of coronary ostia.
- Assessment of coronary arteries (calcification, degree of plaque causing stenosis, plaque type, presence of previously deployed stents regarding site and their patency if feasible, and the need for pre-TAVI invasive selective coronary angiography with or without PCI).
- Assessment of arterial access (minimal lumen diameter, tortuosity, and calcium distribution).
- Assessment of cusp symmetry:
After identifying the aortic annulus on cardiac CT imaging, a parallel plane few millimeters above the aortic annulus, where all 3 commissures are clearly visible, will be used to evaluate cusp symmetry.
The angle between both commissures of each cusp will be measured and the largest cusp will be identified and classified into 4 categories according to the angle of the largest cusp.
- Symmetric (120°-125°)
- Mildly asymmetric (125°-130°)
- Moderately asymmetric (130°-135°)
- Severely asymmetric (> 135°). - Assessment of Coronary ostia eccentricity:
Based on the angle deviation between each coronary ostium and the bisector of the corresponding cusp, the eccentricity of coronary ostia will be classified as:
- Centered (0°-10°).
- Mildly eccentric (10-20°).
- Moderately eccentric (20°-30°).
- Severely eccentric (>30°)
- Coplanar view by using nadir of each cusp at level of annulus.
- Cusp Overlap view by overlapping nadirs of right coronary cusp (RCC) and left coronary cusp (LCC)
- Coronary ostia overlap view using coronary ostium of right coronary artery (RCA) and left coronary artery (LCA) instead of the nadirs of RCC and LCC respectively also at level of annulus, then measuring the difference between two angles in LAO/RAO and Cranial /caudal projection.
- The angular difference between the right/left cusp and coronary ostia overlap view will be calculated by subtracting the latter fluoroscopic angulation from the prior angulation in both right anterior oblique (RAO)/left anterior oblique (RAO/LAO) and caudal/cranial coordinates. Scatterplots will be composed with RAO/LAO angles at the x-axis and cranial/caudal angles at the y-axis, to show the spatial distribution of both fluoroscopic views and to illustrate the intra-patient fluoroscopic angular difference for every patient.
Post-procedural data:
- 12-lead surface electrocardiogram (ECG) immediate post procedure and pre discharge:
- Intrinsic rhythm.
- PR interval duration.
- QRS duration.
- Presence or absence of bundle branch block.
- Changes indicating ongoing myocardial ischemia (Q waves, ST segment depression or elevation and T wave inverted or flat).
- Transthoracic echocardiography immediate post procedure and pre-discharge:
- LV ejection fraction by M- mode and 2D eye balling.
- Resting segmental LV wall motion abnormality.
- Peak and mean pressure gradient across implanted AV.
- Presence of pericardial effusion.
- Presence of paravalvular leakage (PVL) and PVL degree.
- ECG gated MDCT post TAVI:
Post-procedural non contrast enhanced MD cardiac CT imaging will be performed in all patients; Image acquisition will be performed with electrocardiographic gating. All CT data will be reconstructed using images in systolic phase (25-35%) intervals throughout the cardiac cycle with a slice thickness and a slice increment of 0.5 mm and will be analyzed using Osirix viewer software.
Based on identification of neo-commissures by commissural markers (CM) (i.e. commissural posts in Acurate neo 2 and C tap in Evolut R /Pro) assessment of coronary overlap (CO) and commissural misalignment (CMA) can be possible as following:
- Coronary overlap (CO): By measuring the angle between each coronary ostium (RCA and LCA) and nearest neo-commissure and categorize CO into 3 groups
- Severe overlap when < 20°.
- Moderate overlap when 20-35°.
- Optimal overlap when > 35°.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe Aortic stenosis patients underwent trans catheter Aortic valve Implantation | – | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Severe Aortic stenosis with tri-leaflets aortic valve undergoing Trans catheter Aortic valve Implantation
Key inclusion criteria (1 listed)
- Severe Aortic stenosis with tri-leaflets aortic valve undergoing Trans catheter Aortic valve Implantation
Key exclusion criteria (2 listed)
- severe Aortic stenosis with bicuspid leaflets aortic valve
- severe Aortic stenosis undergoing surgical aortic valve replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Coronary Ostia Overlap with neo-commissures
Time frame: With in 30 days from indexed procedure
Measuring angle between trans catheter Aortic valve neo-commissures and coronary Ostia
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.
- Individual participant dataSharing planned: Undecided. share individual participant data may requires participant approval
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Aortic Stenosis and Trans-catheter Aortic Valve Implantation, run by Ain Shams 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 1 inclusion and 2 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?
Coronary Ostia Overlap with neo-commissures (time frame: With in 30 days from indexed procedure). 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 19 Feb 2025.