Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT01672268
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01672268
Study Brief:
Protocol Section:
NCT01672268