NCT02935491

4 Cities for Assessing CAlcification PRognostic Impact After TAVI

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,600 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Heart Disease

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2016-10-17
• Last updated: 2017-03-13

Locations

1 site across 1 country: France