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8110 Gatehouse Road, Falls Church, VA 22042

Supporting Patients Undergoing High-Risk PCI Using a High-Flow Percutaneous Left Ventricular Support Device (SHIELD II)

General Information

Age Group

Adult

Status

Active

Protocol Number

NCT02468778

Background Information

  • The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events
  • The objective of the SHIELD II clinical investigation is to assess the safety and effectiveness of the HeartMate PHP (Percutaneous Heart Pump) System compared to Impella in supporting patients with severe symptomatic coronary artery disease but stable cardiovascular function, who are undergoing elective or urgent high-risk percutaneous coronary intervention (PCI) but are not candidates for coronary artery bypass graft (CABG) surgery
  • This is a prospective, randomized, open-label, multi-center clinical investigation that will register subjects at up to 120 sites in the U.S. and Europe
  • Subjects will be randomly assigned to the HeartMate PHP or Impella in a 2:1 ratio
  • The primary endpoint is a composite of cardiovascular death, myocardial infarction (MI), stroke, repeat revascularization, bleeding of BARC 3 or 5, severe hypotension or aortic insuffiency at 90 days, and Heartmate PHP will be tested for non-inferiority in the primary endpoint compared to Impella
  • Any Impella device approved for use in high-risk PCI can be used as the control device
  • All registered subjects will be followed for 90 days
  • This clinical investigation is conducted to support the pre-market approval of the HeartMate PHP for the indication of high-risk PCI

Offered At

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Alexander Truesdell, MD

Eligibility Information

  • At least 18 years of age
  • Subject is undergoing elective or urgent high-risk PCI procedure and is hemodynamically stable
  • Subject 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
  • Written, signed, and dated informed consent

Imaging Inclusion Criteria:

  • 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 an ejection fraction of <50% 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

Ineligibility Information

  • Emergency PCI
  • Any prior coronary revascularization within the last 6 months
  • Hemodynamically unstable MI with elevated cardiac biomarker (creatinine kinase-MB (CK-MB) or troponin >1X upper limit of normal (ULN)) and no evidence of at least 1 consecutive CKMB or troponin value trending downward from previous value (at least 4 hours apart) OR ST Elevation MI (STEMI) within 72 hours prior to the index procedure regardless of the level of cardiac biomarker
  • Cardiac arrest within 24 hours of procedure requiring cardiopulmonary resuscitation (CPR) or defibrillation
  • Hemodynamic support with the HeartMate PHP post-PCI is anticipated
  • Staged PCI is planned within 90 days following device removal
  • Cardiogenic shock (SBP <90 mmHg for >1 hour with either cool clammy skin OR oliguria OR altered sensorium AND cardiac index <2.2 L/min/m2)
  • History of aortic valve replacement or repair
  • Documented presence of aortic stenosis (orifice area of 1.5cm2 or less)
  • Severe peripheral vascular disease that will preclude the use of a 14F access sheath, which is required for the insertion of the HeartMate PHP catheter
  • Known abnormalities of the aorta that would preclude surgery, including aneurysms and significant tortuosity or calcifications
  • Subject is on hemodialysis
  • Liver dysfunction with elevation of liver enzymes and bilirubin levels to ≥ 3X ULN or Internationalized Normalized Ratio (INR) ≥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 months of procedure
  • Any allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicated
  • Subject is pregnant (For a female subject of childbearing potential, a pregnancy test must be performed within 14 days (≤14 days) prior to the index procedure per site standard test)
  • Participation in another clinical study of an investigational drug or device that has not met its primary endpoint
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results

Imaging Exclusion Criteria:

  • Mural thrombus in the left ventricle
  • Moderate to severe aortic insufficiency by echocardiographic assessment