AMPLATZER Duct Occluder II Additional Sizes (ADO II AS) Clinical Study (CRD 805)
Clinical Trial Information
Trial Contact: Cowden, Amanda
Trial Phone: 321.841.5365
IRB No: 16.162.12
Protocol Abbrev: ADO II AS
Principal Investigator: David Gordon Nykanen, MD
Sub Investigators: Iacono, Karen ARNP; Farias, Michael MD
Phase: Device: Significant Risk
Age Group: Adult; Neonate
Treatment: AMPLATZER Duct Occluder II Aditional Sizes (ADO II AS)
Applicable Disease Sites: Patent Ductus Arteriosus
Therapies Involved: Procedural
ClinicalTrials.gov ID: NCT03055858
The objective of this clinical investigation is to characterize the safety and effectiveness of the ADO II AS device to close the ductus arteriosus in subjects with a patent ductus arteriosus (PDA).
The intended population for this clinical investigation is patients greater than 3 days of age with a PDA with the following measurements: PDA ≤ 4mm in diameter, PDA ≥ 3mm in length requiring closure.