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

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 1-4 at 48 sites in the United States (U.S.) prior to January 30, 2017

- Pivotal Phase: Includes subjects to be registered under the current or 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; each operator must
treat a minimum of 1 and up to 2 subjects with the HeartMate PHP first before becoming
qualified to randomize subjects

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

- 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

- 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

Exclusion Criteria:

- 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
followup 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