Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI

University Hospital, Grenoble70 enrolled

Overview

This is a pilot prospective, comparative, monocentric, randomized study with 2 groups. People with a severe aortic stenosis and a high risk of surgery are referred to a Trans catheter aortic valve implantation (TAVI).

The proposed study is to show the interest of a cardiac computed tomography (CT) to improve the TAVI procedure. The Cardiac computed tomography (CT) shows the exact geometry of the aortic annulus and help the physician to find the right position of the prosthesis during the procedure. The hypothesis is that performing a cardiac CT before the TAVI could reduce the number of vascular peripheral complication, the number of stroke and can minimize the aortic regurgitation during the follow up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Stenosis

Interventions

cardiac computed tomographyOTHER

cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with a symptomatic severe aortic stenosis with a too high risk of surgical valvular replacement. This patient will be selected for a TAVI. In this study, we only randomized patient for a TAVI with an Edwards prosthesis * male or female patient, older than eighteen years old * who have given their written consent * who are affiliated to the French social security system * which has a too high risk of surgical valvular replacement (EuroSCORE logistic \> 20% or Society of Thoracic Surgeons Score \> 10, or contre indicated to a cardiac surgery by a heart team * Severe Aortic stenosis with symptoms like dyspnea, heartache, syncope, heart failure Exclusion Criteria: * Patient who can't give his written consent because of his physical or mental status * Adult patient protect by law (article L1121-8), * Person deprived of liberty (article L1121-8), * Pregnant women * Patient in terminal phase of illness, * Terminal kidney failure * Allergy to iodine * bicuspids ou unicuspid aortic, * Diameter of the left ventricular outflow tract \< 18mm or \> 25mm, * Diameter of the femoral artery \< 7mm, tortuosity or calcifications * Septal hypertrophy * Apical thrombosis.

Locations (1)

University Hospital

Grenoble, France

Outcomes

Primary Outcomes

Composite end point

Composite end point with Stroke (symptoms and CT or MRI), Vascular complications (hematoma with the need of transfusion, dissection of artery/ legs ischemia), and Aortic regurgitation after the procedure, evaluated by transthoracic echocardiography

Time frame: participants will be followed for the duration of 1 year

Secondary Outcomes

To compare results of transthoracic / transoesophageal echocardiography and cardiac CT

• Size of the aortic annulus/ diameter and area

Time frame: inclusion visit

To compare results of transthoracic / transoesophageal echocardiography and cardiac CT

• Left ventricular outflow tract, anatomy of the aortic roots

Time frame: inclusion visit

To compare results of transthoracic / transoesophageal echocardiography and cardiac CT

• Left ventricular function, size, volume

Time frame: inclusion visit

Data from ClinicalTrials.gov

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