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 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT00828334
Eligibility Criteria:
Inclusion Criteria:
* PDA with 4 mm or smaller minimum diameter by color Doppler
* Patent weight \> 5 Kg, Age 6 months to 21 years (Patients older than 21 years may have device implant and be included in a study registry.)
* Previous treatment by surgery or Nit-Occlud device with residual PDA noted at least 6 months after the procedure
* Angiographic minimum PDA diameter (D1) less than 4 mm. (Patients with angiographic diameters larger than 4 mm and smaller or equal to 5 mm may have device implant and be included in a study registry.)
Exclusion Criteria:
* Associated cardiac anomalies requiring surgery
* Known bleeding or blood clotting disorders
* Ongoing febrile illness
* Pregnancy
* Pulmonary hypertension/increased pulmonary vascular resistance (\>5 Wood Units)
* Known hypersensitivity to contrast medium
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
21 Years
Study:
NCT00828334
Study Brief:
Protocol Section:
NCT00828334