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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT02981004
Eligibility Criteria:
Inclusion Criteria:1.Patient has an indication for primary, isolated aortic valve implantation 2. Patient is above 18 Years old 3. Patient has signed patient informed consent 4. foreseen implantation of an Epic, Epic supra or Trifecta valve 5. Patient has sinus rhythm
Exclusion Criteria:
1. Patient is younger than 18 years
2. Patient has active endocarditis
3. Patient is not able or does not want to participate on follow-up
4. Patient is pregnant or nursing
5. Surgical widening of outflow tract is planned
6. Left ventricular ejection fraction is smaller than 50%
7. Patient has a mitral valve or tricuspid valve insufficiency or stenosis bigger or equal Grade II
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02981004
Study Brief:
Protocol Section:
NCT02981004