4 Cities for Assessing CAlcification PRognostic Impact After TAVI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-03-31

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).

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Detailed Description

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Conditions

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Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Transcatheter Aortic Valve Implantation

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

Transcatheter Aortic Valve Implantation (TAVI)

Intervention Type DEVICE

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

Interventions

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Transcatheter Aortic Valve Implantation (TAVI)

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

Intervention Type DEVICE

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.