SHIELD II

Coronary InterventionS in HIgh-Risk PatiEnts Using a Novel Percutaneous Left Ventricular Support Device (SHIELD II)

November 22, 2017

  • Clinical Trial Information

    Trial Contact: DuPont, Ashley

    Trial Phone: 321.841.1505

  • IRB No: 16.022.02

    Principal Investigator: Vijaykumar S Kasi, MD

    Sub Investigators: Steiner, Mark MD; Gupta, Ashish MD; Khawaja, Farhan MD; Vivek, Deepak MD; Garcia Fernandez, Joel A MD

    Phase: Device: Significant Risk

    Age Group: Adult

    Secondary Protocol No: Version 2: 05/19/2015

    Treatment: Procedural

    Applicable Disease Sites: CAD

    Therapies Involved: Heartmate PHP

    ClinicalTrials.gov ID: NCT02468778

  • Objective

    The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction.

  • Key Eligibility

    Need for High Risk PCI, EF <35%