NCT06834828

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed
Last Updated

February 19, 2025

Status Verified

July 1, 2023

Enrollment Period

1.5 years

First QC Date

February 14, 2025

Last Update Submit

February 14, 2025

Conditions

Severe Aortic StenosisTrans-catheter Aortic Valve ImplantationCoronary Ostial Eccentricity

Outcome Measures

Primary Outcomes (1)

  • Coronary Ostia Overlap with neo-commissures

    Measuring angle between trans catheter Aortic valve neo-commissures and coronary Ostia

    With in 30 days from indexed procedure

Study Arms (1)

Severe Aortic stenosis patients underwent trans catheter Aortic valve Implantation

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- Severe Aortic stenosis with tri-leaflets aortic valve undergoing Trans catheter Aortic valve Implantation

You may qualify if:

  • Severe Aortic stenosis with tri-leaflets aortic valve undergoing Trans catheter Aortic valve Implantation

You may not qualify if:

  • severe Aortic stenosis with bicuspid leaflets aortic valve
  • severe Aortic stenosis undergoing surgical aortic valve replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Ain Shams University

Abbasia, Cairo Governorate, 11517, Egypt

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2025

First Posted

February 19, 2025

Study Start

June 1, 2023

Primary Completion

December 1, 2024

Study Completion

January 1, 2025

Last Updated

February 19, 2025

Record last verified: 2023-07

Locations

EG(1)