NIT-OCCLUD PDA Phase II Sentinel Trial

- 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.)

- 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