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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT04012060
Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing an isolated biological aortic valve replacement for a severe and/or symptomatic aortic valve stenosis, defined as:
* An aortic valve area of ≤1.0cm2, and;
* Mean valve gradient ≥40mmHg, and/or;
* A peak velocity of at least 4.0m/s.
* Able to understand the nature of the study and what will be required of them;
* All adult men and non-pregnant women;
* BMI between 18-35.
Exclusion Criteria:
* Inability to give written informed consent;
* Inability to adequately answer the questionnaires;
* Patients requiring additional cardiac surgery during the same procedure;
* Patients requiring a reoperation;
* (relative) contraindications for a limited access approach;
* Undergoing an emergency operation;
* Recent myocardial infarction (\<90 days);
* Recent stroke or transient ischemic attack (\<6 months);
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04012060
Study Brief:
Protocol Section:
NCT04012060