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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Coronary Ostia Overlap with neo-commissures
Study Overview
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).
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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Severe Aortic stenosis with tri-leaflets aortic valve undergoing Trans catheter Aortic valve Implantation
Exclusion Criteria
- •severe Aortic stenosis with bicuspid leaflets aortic valve
- •severe Aortic stenosis undergoing surgical aortic valve replacement
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported