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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Egypt

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:

  1. 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).
  1. 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).
  1. 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.
  1. 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.

  1. Symmetric (120°-125°)
  2. Mildly asymmetric (125°-130°)
  3. Moderately asymmetric (130°-135°)
  4. 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:

  1. Centered (0°-10°).
  2. Mildly eccentric (10-20°).
  3. Moderately eccentric (20°-30°).
  4. 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:

  1. 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).
  1. 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.
  1. 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
  1. Severe overlap when < 20°.
  2. Moderate overlap when 20-35°.
  3. Optimal overlap when > 35°.
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 groups in NCT06834828
Study groupRoleWhat they receive
Severe Aortic stenosis patients underwent trans catheter Aortic valve ImplantationNot described

What is being measured

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

  1. 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.

  1. First posted19 Feb 2025
  2. Study start1 Jun 2023
  3. Primary completion1 Dec 2024
  4. Study completion1 Jan 2025

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
64 participants (actual)
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

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.

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