Closure of Muscular Ventricular Septal Defects with the Amplatzer Muscular VSD Occluder

January 17, 2018

Closure of Muscular Ventricular Septal Defects with the Amplatzer Muscular VSD Occluder Post Approval Study

  • Clinical Trial Information

    Trial Contact: Cowden, Amanda

    Trial Phone: 321.841.5365

  • IRB No: 07.118.12

    Protocol Abbrev: VSD

    Principal Investigator: David Gordon Nykanen, MD

    Phase: Device: Non-significant Risk

    Age Group: Adult;Pediatric

    Treatment: Device

    Therapies Involved: Procedural

    ClinicalTrials.gov ID: NCT00647387

  • Objective

    This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER Muscular VSD Occluder.

  • Key Eligibility

    1). Complex congenital muscular ventricular septal defects (VSD) of significant size to warrant closure. 2).Subjects must meet at least one of the following criteria to be considered high risk for standard transatrial or transarterial surgical closure based on anatomical conditions:
    a. Left ventriculotomy or an extensive right ventriculotomy,
    b. Failed previous VSD closure,
    c. Multiple apical and/or anterior muscular VSDs ("Swiss Cheese Septum"), and/or
    d. Posterior apical VSDs covered by trabeculae.
    e. Overall medical condition