AMPLATZER Duct Occluder II Additional Sizes (ADO II AS) Study

AMPLATZER Duct Occluder II Additional Sizes (ADO II AS) Clinical Study (CRD 805)

November 22, 2017

  • 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: Procedural

    Applicable Disease Sites: Patent Ductus Arteriosus

    Therapies Involved: AMPLATZER Duct Occluder II Aditional Sizes (ADO II AS)

    ClinicalTrials.gov ID: NCT03055858

  • Objective

    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).

  • Key Eligibility

    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.