4 Cities for Assessing CAlcification PRognostic Impact After TAVI

NCT02935491 | Completed

• 1 other identifier: 69HCL16_0651
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cardiovascular mortality

  Number of death of cardiovascular cause will be analyzed

  censored on 3 March 2017

Secondary Outcomes (4)

• 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 Arms (1)

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)

Interventions

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

Transcatheter Aortic Valve Implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

MeSH Terms

Conditions

Heart Diseases; Aortic Valve Stenosis; Calcinosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 17, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 13, 2017

Record last verified: 2017-03

Locations

FR (1)