C4CAPRI: 4 Cities for Assessing CAlcification PRognostic Impact After TAVI

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT02935491

Collaborator

(none)

1,600

Enrollment

Location

Actual Duration (Months)

145.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Heart Disease	Device: Transcatheter Aortic Valve Implantation (TAVI)

Study Design

Study Type:

Observational

Actual Enrollment :

1600 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

4 Cities for Assessing CAlcification PRognostic Impact After TAVI

Actual Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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	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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Cardiovascular mortality [censored on 3 March 2017]
Number of death of cardiovascular cause will be analyzed

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.