SHIELD II - Supporting Patient Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device

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.
NCT02468778
Heart & Vascular, Heart & Vascular - Interventional Cardiology Trials
John L. Petersen II, MD

Inclusion Criteria:

  • At least 18 years of age
  • Patient is undergoing elective or urgent high risk PCI procedure and is hemodynamically stable
  • Patient is indicated for a revascularization of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
  • A heart team, including a cardiac surgeon, has determined high risk PCI is an acceptable therapeutic option
  • The presence of complex coronary artery disease (CAD) makes hemodynamic instability resulting from repeat episodes of reversible myocardial ischemia during PCI likely. Complex CAD is defined as:

    o an ejection fraction of ≤35% AND at least one of the following:

    • intervention of the last patent coronary conduit, OR
    • intervention of an unprotected left main artery, OR
    • intervention on patient presenting with triple vessel disease defined as at least one significant stenosis (at least 50% diameter stenosis on visual assessment) in all three major epicardial territories
  • Written, signed, and dated informed consent

Exclusion Criteria:

  • • Emergency PCI
  • Any prior coronary revascularization within the last six months
  • Myocardial infarction at baseline defined as:

ST Elevation MI (STEMI):

Subject has clinical symptoms and/or ECG changes (new pathological Q waves in 2 contiguous leads) consistent with acute ST elevation MI (STEMI) within 72 hours prior to the index procedure.

Non-STEMI:

Hemodynamically unstable with biomarker elevation (CK-MB or Troponin >1x URL) and/or no evidence of at least 1 consecutive troponin or CK-MB value trending downward from previous value.

URL = upper range limit, defined as 99th percentile of normal reference range

  • Cardiac arrest within 24 hours of procedure requiring CPR or defibrillation
  • Hemodynamic support with the HeartMate PHP post-PCI is anticipated
  • Cardiogenic shock (systolic blood pressure (SBP) <90 mmHg for >1 hour with either cool clammy skin OR oliguria OR altered sensorium AND cardiac index <2.2 L/min/m2)
  • Mural thrombus in the left ventricle
  • History of aortic valve replacement
  • Documented presence of aortic stenosis (orifice area of 1.5cm2 or less)
  • Moderate to severe aortic insufficiency by echocardiographic assessment
  • Severe peripheral vascular disease
  • Known abnormalities of the aorta that would preclude surgery, including aneurysms and significant tortuosity or calcifications
  • Patient is on hemodialysis
  • Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3x upper limit of normal (ULN) or INR (International Normalized Ratio) ≥2 or lactate dehydrogenase (LDH) > 2.5x ULN.
  • Uncorrectable abnormal coagulation parameters (platelet count ≤75000/mm3 or INR ≥2.0 or fibrinogen ≤1.5 g/l)
  • Active systemic infection requiring treatment with antibiotics
  • Stroke or transient ischemic attack (TIA) within 6 month of procedure
  • Any allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated
  • Patient is pregnant
  • Participation in another clinical study of an investigational drug or device that has not met its primary endpoint
Charlene Boisjolie, RN
206-215-2455
206-215-1500