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 @ 2:13 PM
Ignite Modification Date:
2025-12-24 @ 2:13 PM
NCT ID:
NCT04105595
Eligibility Criteria:
Inclusion Criteria:
* Patient suffers from ASD (including ostium secundum ASD or a fenestration from a Fontan procedure) or PFO and is planned to receive the CBSO.
* Patient (or legal guardian) has been informed and agreed to and signed the informed consent form.
* A CBSO is implanted into the patient.
Exclusion Criteria:
* Patient is known to have one or more of the contraindications listed in the instructions for use.
* Patient is currently participating in one or more interventional studies, with exception of a study investigating the CBSO.
* Patient is implanted with another product in the atrial septum.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04105595
Study Brief:
Protocol Section:
NCT04105595