Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI

Study Overview
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Brief Summary
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This is a pilot prospective, comparative, monocentric, randomized study with 2 groups. People with a severe aortic stenosis and a high risk of surgery are referred to a Trans catheter aortic valve implantation (TAVI).

Detailed Description
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The proposed study is to show the interest of a cardiac computed tomography (CT) to improve the TAVI procedure. The Cardiac computed tomography (CT) shows the exact geometry of the aortic annulus and help the physician to find the right position of the prosthesis during the procedure. The hypothesis is that performing a cardiac CT before the TAVI could reduce the number of vascular peripheral complication, the number of stroke and can minimize the aortic regurgitation during the follow up.

Official Title
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Interest of Cardiac Computed Tomography (CT) to Optimize and Improve the Procedure of Transcatheter Aortic Valve Implantation (TAVI)

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Other: cardiac computed tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with a symptomatic severe aortic stenosis with a too high risk of surgical valvular replacement. This patient will be selected for a TAVI. In this study, we only randomized patient for a TAVI with an Edwards prosthesis male or female patient, older than eighteen years old who have given their written consent who are affiliated to the French social security system which has a too high risk of surgical valvular replacement (EuroSCORE logistic > 20% or Society of Thoracic Surgeons Score > 10, or contre indicated to a cardiac surgery by a heart team Severe Aortic stenosis with symptoms like dyspnea, heartache, syncope, heart failure Exclusion Criteria: Patient who can't give his written consent because of his physical or mental status Adult patient protect by law (article L1121-8), Person deprived of liberty (article L1121-8), Pregnant women Patient in terminal phase of illness, Terminal kidney failure Allergy to iodine bicuspids ou unicuspid aortic, Diameter of the left ventricular outflow tract < 18mm or > 25mm, Diameter of the femoral artery < 7mm, tortuosity or calcifications Septal hypertrophy Apical thrombosis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard TAVI procedure<br>Patients without Cardiac CT measures before TAVI | Other: cardiac computed tomography<br>* cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy<br>* Other names: Transcatheter Aortic Valve Implantation;|
| Experimental: Cardiac CT scan before TAVI procedure<br>patients with cardiac CT measures before TAVI | Other: cardiac computed tomography<br>* cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy<br>* Other names: Transcatheter Aortic Valve Implantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite end point | Composite end point with Stroke (symptoms and CT or MRI), Vascular complications (hematoma with the need of transfusion, dissection of artery/ legs ischemia), and Aortic regurgitation after the procedure, evaluated by transthoracic echocardiography | participants will be followed for the duration of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare results of transthoracic / transoesophageal echocardiography and cardiac CT | • Size of the aortic annulus/ diameter and area | inclusion visit | 
| To compare results of transthoracic / transoesophageal echocardiography and cardiac CT | • Left ventricular outflow tract, anatomy of the aortic roots | inclusion visit | 
| To compare results of transthoracic / transoesophageal echocardiography and cardiac CT | • Left ventricular function, size, volume | inclusion visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy