4 Cities for Assessing CAlcification PRognostic Impact After TAVI

Study Overview
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Brief Summary
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Transcatheter Aortic Valve Implantation (TAVI) indications are progressing rapidly as an alternative to conventional surgery for aortic stenosis cure. Despite a high rate of procedural success, some patients do not benefit from the procedure. The investigators hypothesis is that aortic stiffness may be of major prognostic significance after stenosis relief. The aim of this study is to test the prognostic impact of aortic stiffness estimated by the volume of calcifications of the thoracic aorta on the CT-scan performed systematically before the procedure. This prognostic value will be assessed in 4 independent cohorts issued from 4 french cities (Lyon, Rouen, Paris, Clermont-Ferrand).

Official Title
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4 Cities for Assessing CAlcification PRognostic Impact After TAVI

Conditions
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Heart Disease

Intervention / Treatment
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* Device: Transcatheter Aortic Valve Implantation (TAVI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 Patient who underwent a transcatheter aortic valve implantation Patient who provided informed, written consent to participate to FRANCE TAVI study Patient for whom a CT-Scan performed before TAVI procedure is available. Exclusion Criteria: none

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transcatheter Aortic Valve Implantation<br>Lyon and Paris cohorts : 900 patients will be used to test the prognostic value of aortic calcifications and to propose a risk score Clermont and Rouen cohorts (700 patients) will be used to test in an independent group, the predictive value of the risk score | Device: Transcatheter Aortic Valve Implantation (TAVI)<br>* TAVI is a well-accepted method for aortic valve replacement without surgery. It is currently proposed to patients at high surgical risk or contraindicated to surgery. It consists of introducing a valve inserted inside a stent by the femoral artery in most cases. Aortic calcifications will be determined by the analysis of the CT-scan performed systematically before the procedure. A semi-automated software (CreaTools) will be used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality | Number of death of cardiovascular cause will be analyzed | censored on 3 March 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause deaths | Number of death of all causes will be analyzed | censored on 3 March 2017 | 
| left ventricular remodeling | Echocardiographic measure will be done | censored on 3 March 2017 | 
| left ventricular ejection fraction | Echocardiographic measure will be done | censored on 3 March 2017 | 
| diastolic function | Echocardiographic measure will be done | censored on 3 March 2017 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, Aortic stenosis, aortic stiffness, calcifications, CT-scan, Vascular impedance