Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (SHIELD II)
Supporting Patients Undergoing HIgh-Risk PCI Using a High-Flow PErcutaneous Left Ventricular Support Device (SHIELD II)
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.
Prospective, randomized, multi-center, open-label trial of the HeartMate PHP at up to 120
 sites in the US and Europe. Control device will be any Abiomed Impella device approved for
 use in high-risk PCI.

 This clinical investigation is divided into two phases, a feasibility phase and a pivotal
 phase.

 -  Feasibility Phase: Includes 75 roll-in and 120 randomized subjects registered under the
 CIP versions 2-4 at 48 sites in the United States (U.S.) prior to January 30, 2017

 -  Pivotal Phase: Includes subjects to be registered under Version F or a later version of
 the CIP at up to 120 sites in the U.S. and Europe

 Non-randomized Roll-in Cohort: Up to 480 subjects with the HeartMate PHP.

 Randomized Cohort: A minimum of 473 and a maximum of 716 subjects will be randomized in a 2:1
 ratio to the HeartMate PHP and Impella.
Inclusion Criteria:

 -  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

 -  Subject must provide written informed consent prior to any clinical investigation
 related procedure

 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% by echocardiographic assessment 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

 Exclusion Criteria:

 -  Emergency PCI

 -  Any prior coronary revascularization within the last 6 months

 -  Any 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

 -  Any use of a mechanical circulatory support device within 14 days prior to the index
 procedure (Note: Subjects must be hemodynamically stable without any hemodynamic
 support to be eligible for this clinical investigation.)

 -  Hemodynamic support with a mechanical circulatory support device (e.g.the HeartMate
 PHP, Impella, intra-aortic balloon pump (IABP), or extra-corporeal membrane
 oxygenation (ECMO)) post-PCI is anticipated.

 -  Any condition that requires discontinuation of antiplatelet and/or anticoagulant
 therapy within 90 days following the index procedure (e.g. planned noncardiac surgery)

 -  Any use of vasopressors or inotropes within 24 hours prior to the index procedure

 -  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

 -  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) ≥1.6 or lactate dehydrogenase (LDH) > 2.5X
 ULN

 -  Abnormal coagulation parameters (platelet count ≤75000/mm3 or INR ≥1.6 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
 (including heparin), 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
 followup requirements, or impact the scientific soundness of the clinical
 investigation results

 -  Life expectancy <1 year

 Imaging Exclusion Criteria:

 -  Mural thrombus in the left ventricle

 -  Documented present of aortic stenosis (orifice area of 1.52 cm^2 or less)

 -  Moderate to severe aortic insufficiency by echocardiographic assessment