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:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT03280433
Eligibility Criteria:
Inclusion Criteria:
* symptomatic severe aortic stenosis patients (defined as aortic valve area of \< 1 cm2 or 0.6 cm2/m2 by transthoracic echocardiography) referred to aortic valve replacement.
Exclusion Criteria:
* diagnosis of acute coronary syndrome in the last 3 months.
* prior history of persistent or permanent atrial or flutter fibrillation.
* coexisting moderate to severe aortic valve regurgitation or moderate to severe mitral valve disease, bicuspid aortic valve.
* left ventricular dilatation \[end-diastolic volume index \>75 mL/m²\].
* left ventricular ejection fraction \<55%.
* chronic renal failure stage 3 to 5 defined as glomerular filtration rate GFR estimated by Cockcroft-Gault formula adjusted for body surface area \< 30 mL/min/1.73m².
* moderate to severe chronic obstructive pulmonary disease defined as forced expiratory volume in one second \<50% according to the 2011 Global Initiative for Chronic Obstructive Pulmonary Disease guidelines.
* active malignancy (i.e. With no evidence of recurrence and no longer receiving active treatment).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03280433
Study Brief:
Protocol Section:
NCT03280433