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Clinical Trials/NCT02935491
NCT02935491
Completed
Not Applicable

4 Cities for Assessing CAlcification PRognostic Impact After TAVI

Hospices Civils de Lyon1 site in 1 country1,600 target enrollmentApril 2016
ConditionsHeart Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Disease
Sponsor
Hospices Civils de Lyon
Enrollment
1600
Locations
1
Primary Endpoint
Cardiovascular mortality
Status
Completed
Last Updated
9 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
March 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Cardiovascular mortality

Time Frame: censored on 3 March 2017

Number of death of cardiovascular cause will be analyzed

Secondary Outcomes

  • All-cause deaths(censored on 3 March 2017)
  • left ventricular remodeling(censored on 3 March 2017)
  • left ventricular ejection fraction(censored on 3 March 2017)
  • diastolic function(censored on 3 March 2017)

Study Sites (1)

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