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 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT04406805
Eligibility Criteria:
Inclusion Criteria:
* Informed consent to participate in the study
* Severe aortic stenosis, defined as aortic valve area \<1.0 cm2 or aortic valve area index \<0.6 cm2/m2 as calculated by the continuity equation on transthoracic echocardiography, regardless of the transvalvular gradient, with or without coexisting symptoms of heart failure
* Qualification for surgical aortic valve replacement or transcatheter aortic valve implantation by the Heart Team in accordance with European Society of Cardiology guidelines
Exclusion Criteria:
* Heart failure of etiology other than aortic stenosis
* Coexisting, haemodynamically significant aortic regurgitation
* Myocardial infarction within the last 3 months
* Coronary revascularization within the last month or planned during transcatheter aortic valve implantation or surgical aortic valve replacement
* Chronic kidney disease with estimated glomerular filtration rate \<45 ml/min/1.73 m2
* Acute gastrointestinal disease within the last month
* Active neoplastic disease
* Chronic inflammatory disease
* Autoimmune disease
* Chronic intestinal disease
* Antibiotic therapy within the last 2 months
* Dietary supplements within the last 7 days
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04406805
Study Brief:
Protocol Section:
NCT04406805