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4 Cities for Assessing CAlcification PRognostic Impact After TAVI

4 Cities for Assessing CAlcification PRognostic Impact After TAVI

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02935491
Acronym
C4CAPRI
Enrollment
1600
Registered
2016-10-17
Start date
2016-04-30
Completion date
2017-03-31
Last updated
2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Disease

Keywords

TAVI, Aortic stenosis, aortic stiffness, calcifications, CT-scan, Vascular impedance

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).

Interventions

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular mortalitycensored on 3 March 2017Number of death of cardiovascular cause will be analyzed

Secondary

MeasureTime frameDescription
All-cause deathscensored on 3 March 2017Number of death of all causes will be analyzed
left ventricular remodelingcensored on 3 March 2017Echocardiographic measure will be done
left ventricular ejection fractioncensored on 3 March 2017Echocardiographic measure will be done
diastolic functioncensored on 3 March 2017Echocardiographic measure will be done

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026