Clinical trial NCT01672268: Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI
Official title: Interest of Cardiac Computed Tomography (CT) to Optimize and Improve the Procedure of Transcatheter Aortic Valve Implantation (TAVI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Aortic Stenosis
Keywords: cardiac computed tomography
Transcatheter Aortic Valve Implantation
safety and efficacy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2012-08-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite end point
timeFrame: participants will be followed for the duration of 1 year
Secondary outcomes:
measure: To compare results of transthoracic / transoesophageal echocardiography and cardiac CT
timeFrame: inclusion visit
measure: To compare results of transthoracic / transoesophageal echocardiography and cardiac CT
timeFrame: inclusion visit
measure: To compare results of transthoracic / transoesophageal echocardiography and cardiac CT
timeFrame: inclusion visit
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Gilles MD BARONE ROCHETTE
role: PRINCIPAL_INVESTIGATOR
References: