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 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT05893758
Eligibility Criteria:
Inclusion Criteria:
1. Patients with a confirmed diagnosis of Patent Foramen Ovale (PFO);
2. Associated with TIA or cryptogenic stroke;
3. Patients was implanted with the investigational device as per IFU instructions;
4. Patients or legally authorized representatives have signed Data Release Consent or equivalent documents.
Exclusion Criteria:
1. Any contraindication mentioned in the corresponding IFU;
2. Patients did not conduct any follow up visit after hospital discharge.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05893758
Study Brief:
Protocol Section:
NCT05893758