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

NCT ID: NCT01672268

Last Updated: 2014-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-11-30

Brief Summary

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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

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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.

Conditions

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Aortic Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard TAVI procedure

Patients without Cardiac CT measures before TAVI

Group Type ACTIVE_COMPARATOR

cardiac computed tomography

Intervention Type OTHER

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

Cardiac CT scan before TAVI procedure

patients with cardiac CT measures before TAVI

Group Type EXPERIMENTAL

cardiac computed tomography

Intervention Type OTHER

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

Interventions

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cardiac computed tomography

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

Intervention Type OTHER

Other Intervention Names

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Transcatheter Aortic Valve Implantation

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles MD BARONE ROCHETTE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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University Hospital

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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2011-A001113-38

Identifier Type: OTHER

Identifier Source: secondary_id

2011-A001113-38

Identifier Type: -

Identifier Source: org_study_id