Shield II

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

Shield II [NCT02468778]

Description: 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.

Device: HeartMate PHP; Device: Abiomed Impella® Recover® LP 2.5

Primary Investigator: Kong

Drug/Device Information
Assess the safety and efficacy of the HeartMate PHP in supporting patients with severe symptomatic coronary artery disease with diminished but stable cardiovascular function
Undergoing elective or urgent high risk percutaneous coronary interventions (PCI) but are not candidates for coronary artery bypass graft (CABG) surgery
The key feature of the PHP system is its ability for percutaneous delivery
The cannula and impeller assembly is delivered sheathed
13 Fr insertion profile and expands to 24F when deployed across the aortic valve and into the left ventricle
The PHP system is designed to provide an average flow of over 4 liters per minute against a pressure of 60 mmHg
Randomized in a 2:1 fashion (2 PHP : 1 Impella)
Thoratec Corporation
Major Inclusion and Exclusion
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 that includes a cardiac surgeon who has seen the patient, has determined that high risk PCI is the appropriate option
Complex CAD is defined as: A or B
A. EF ≤ 35% AND an intervention of the last patent coronary conduit OR an unprotected left main artery
B. EF ≤ 35% AND intervention on patient with triple vessel disease defined at least 50% diameter stenosis in all three major epicardial territories
No emergency PCI
No myocardial infarction at baseline
No cardiac arrest within 24 hours of procedure requiring CPR or defibrillation
No mural thrombus in the left ventricle
No history of aortic valve replacement
No documented presence of aortic stenosis (orifice area of 1.5cm2 or less)
No hemodialysis