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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT03055858
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of a PDA
* PDA ≤ 4mm in diameter
* PDA ≥ 3mm in length
* Subject (or legally authorized representative) is willing to comply with all pre-procedure, post-procedure, and follow-up testing requirements and provides consent to participate in the clinical study
NOTE: This study is enrolling children and all local laws and governing IRB requirements will be followed for obtaining informed consent
Exclusion Criteria:
* Weight \< 700 grams at time of the procedure
* Age \< 3 days at time of procedure
* Coarctation of the aorta
* Left pulmonary artery stenosis
* Cardiac output that is dependent on right to left shunt through the patent ductus arteriosus due to pulmonary hypertension
* Intracardiac thrombus
* Active infection requiring treatment at the time of implant
* Female subjects of child bearing potential are either pregnant or desire to become pregnant within six months post implant
* Other disease process likely to limit survival to less than six (6) months
* Participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Days
Study:
NCT03055858
Study Brief:
Protocol Section:
NCT03055858