4 Cities for Assessing CAlcification PRognostic Impact After TAVI (C4CAPRI)

March 10, 2017 updated by: Hospices Civils de Lyon

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • Hopital de la Croix Rousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of both sex presenting with a severe aortic stenosis with the indication of aortic replacement by TAVI

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular mortality
Time Frame: censored on 3 March 2017
Number of death of cardiovascular cause will be analyzed
censored on 3 March 2017

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 17, 2016

Study Record Updates

Last Update Posted (Actual)

March 13, 2017

Last Update Submitted That Met QC Criteria

March 10, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0651

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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