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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT04035356
Eligibility Criteria:
Inclusion Criteria:
* The patient underwent or is undergoing aortic valve repair using either the HAART 300 or HAART 200 Aortic Annuloplasty Device in accordance with the Instructions for Use.
* The patient has reviewed and signed the written informed consent form.
* The patient agrees to return for all follow-up evaluations for the duration of the study.
Exclusion Criteria:
* Retrospective patient that has undergone a subsequent aortic valve replacement procedure.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04035356
Study Brief:
Protocol Section:
NCT04035356