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Completed

NCT Number: NCT02935491

4 Cities for Assessing CAlcification PRognostic Impact After TAVI

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).

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Key information

Conditions

Heart Disease Aortic Valve Disease Aortic Valve Stenosis Calcinosis Calcium Metabolism Disorders Cardiovascular Diseases Heart Diseases Heart Valve Diseases Metabolic Diseases Nutritional and Metabolic Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital de la Croix Rousse

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcatheter Aortic Valve Implantation (TAVI)

Device

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

Primary outcomes

  1. Cardiovascular mortality

    Time frame: censored on 3 March 2017

    Number of death of cardiovascular cause will be analyzed

Secondary outcomes

  1. All-cause deaths

    Time frame: censored on 3 March 2017

    Number of death of all causes will be analyzed

  2. left ventricular remodeling

    Time frame: censored on 3 March 2017

    Echocardiographic measure will be done

  3. left ventricular ejection fraction

    Time frame: censored on 3 March 2017

    Echocardiographic measure will be done

  4. diastolic function

    Time frame: censored on 3 March 2017

    Echocardiographic measure will be done

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: C4CAPRI

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2016
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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