4 Cities for Assessing CAlcification PRognostic Impact After TAVI

Heart Disease Clinical Trial

— C4CAPRI  

Official title:

4 Cities for Assessing CAlcification PRognostic Impact After TAVI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935491
• Other study ID #: 69HCL16_0651
• Status: Completed
• Phase: N/A
• First received: October 14, 2016
• Last updated: March 10, 2017
• Start date: April 2016
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Calcinosis
• Heart Disease
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
France	Hôpital de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular mortality	Number of death of cardiovascular cause will be analyzed	censored on 3 March 2017
Secondary	All-cause deaths	Number of death of all causes will be analyzed	censored on 3 March 2017
Secondary	left ventricular remodeling	Echocardiographic measure will be done	censored on 3 March 2017
Secondary	left ventricular ejection fraction	Echocardiographic measure will be done	censored on 3 March 2017
Secondary	diastolic function	Echocardiographic measure will be done	censored on 3 March 2017