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 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT02818959
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with severe native aortic valve stenosis
* NYHA functional class II or higher
* Increased risk for surgical aortic valve replacement
* Comply with post-operative follow-up visits and requirements
Exclusion Criteria:
* Combined aortic valve disease with severe aortic insufficiency
* Presence of moderate mitral insufficiency or previous mitral prosthesis
* Severe pulmonary hypertension
* Congenital uni- or bicuspid aortic valve
* Endocarditis or active infection
* Life expectancy \< 12 months
* Need for emergency surgery for any reason
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
75 Years
Study:
NCT02818959
Study Brief:
Protocol Section:
NCT02818959