4 Cities for Assessing CAlcification PRognostic Impact After TAVI

Completed

• Conditions: Heart Disease
• Interventions: Device: Transcatheter Aortic Valve Implantation (TAVI)

• Registration Number: NCT02935491
• Lead Sponsor: Hospices Civils de Lyon

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-17
• Status Verified: 2017-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-10
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1600

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.

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Exclusion Criteria

• none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transcatheter Aortic Valve Implantation	Transcatheter Aortic Valve Implantation (TAVI)	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

Primary Outcome Measures

Name	Time	Method
Cardiovascular mortality	censored on 3 March 2017	Number of death of cardiovascular cause will be analyzed

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital de la Croix Rousse; 🇫🇷 Lyon, France