4 Cities for Assessing CAlcification PRognostic Impact After TAVI (C4CAPRI)

Civil Hospices of Lyon

Status: Completed

Conditions: Heart Disease

Treatments: Device: Transcatheter Aortic Valve Implantation (TAVI)

Study type: Observational

Funder types: Other

Identifiers

NCT02935491

69HCL16_0651

Details and patient eligibility

About

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).

Enrollment: 1,600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,600 participants in 1 patient group

Transcatheter Aortic Valve Implantation

Description:

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

Treatment:

Device: Transcatheter Aortic Valve Implantation (TAVI)