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 @ 4:23 PM
Ignite Modification Date:
2025-12-24 @ 4:23 PM
NCT ID:
NCT02260466
Eligibility Criteria:
Inclusion Criteria:
* Significant aortic stenosis. The aortic stenosis severity (aortic area : \<1cm² or \<0.6cm²/m² measured by echocardiography
* Indication of surgical aortic valve replacement for AS: will be defined in each center in accordance with ESC guidelines.
* Patient ≥ 70 years old and NYHA class ≥2 and LVEF \<60% or global LV strain more than "-17%".
* Written consent prior to surgery.
Exclusion Criteria:
* Other severe disease with a life prognosis below than 1 year.
* Already known other causes of amyloidosis than senile amyloidosis will be excluded.
* Patients unsuitable for AS surgery as defined by ESC guidelines 2012.
* Significant mitral valve disease needing a surgical treatment.
* Significant aortic regurgitation (class \>III).
NB: Patients with pacemaker will be included but will not perform the cardiac MRI.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02260466
Study Brief:
Protocol Section:
NCT02260466