AMPLATZER PFO Occluder Post Approval Study

February 21, 2018

  • Clinical Trial Information

    Trial Contact: Noel, Henry

    Trial Phone: 321.841.3686

  • IRB No: 17.124.10

    Protocol Abbrev: AMPLATZER PFO

    Principal Investigator: Vijaykumar S Kasi, MD

    Sub Investigators: Nykanen, David MD; Vivek, Deepak MD; Rosado, Christian

    Phase: Device: Category N/A

    Age Group: Adult

    Secondary Protocol No: CRD_806

    Treatment: Procedural

    Applicable Disease Sites: Stroke, CVA, PFO

    Therapies Involved: DEVICE: AMPLATZER PFO Occluder ID: NCT03309332

  • Objective

    Assessing the 30-day rate of device- or procedure-related serious adverse events including those that led to death. And to demonstrate that the AMPLATZERTM PFO Occluder is effective by assessing the rate of recurrent ischemic stroke through 5 years.

  • Key Eligibility

    1. History of PFO
    2. CVA within 270 days
    3. Cryptogenic Stroke