CSI Percutaneous Ventricular Assist Device (pVAD) Second in Human Study

The purpose of this study is to collect data on safety and device performance on the CSI pVAD System used to support hemodynamic stability during HR-PCIs to inform device design and finalization.

Inclusion Criteria:Subject is ≥18 years of ageIn the investigator's opinion, the subject is capable of providing informed consent.Subject has signed the Independent Ethics Committee (IEC) approved study Informed Consent Form (ICF) prior to any study related proceduresSubject has a life expectancy ≥1 yearSubject has a left ventricular ejection fraction (LVEF) ≥15% and ≤40%Subject has a planned elective or urgent high risk percutaneous coronary intervention with hemodynamic supportSubject of child bearing potential has a negative pregnancy test resultExclusion Criteria:Subject has ST-Elevation Myocardial Infarction (STEMI) within 30 days prior to study procedure based on criteria in SCAI definitionSubject has NSTEMI with cardiac enzymes that are not trending downward within 30 days prior to study procedureSubject with RV failure (defined as reduced RV function on imaging and evidence of increased CVP >18 mmHg)Subject with history of cardiac arrest within 30 days prior to study procedure requiring cardiopulmonary resuscitation OR any history of cardiac arrest with impairment in mental status, cognition or any global or functional neurological deficitSubject is in cardiogenic shock (defined as systolic BP <90 mmHg, cardiac index <2.1 and/or evidence of impaired end organ perfusion) that is not responsive to fluid infusion or requiring any inotropic or pressor supportSubject received any pressors or inotropes within 24 hours prior to the start of the study procedureSubject has evidence of current or prior endocarditisSubject with active myocarditisSubject had a deep vein thrombosis (DVT) or pulmonary embolism (PE) within 6 months prior to study procedureSubject had a stroke or TIA within 6 months prior to study procedureSubject had previous CABG within 6 months prior to study procedureSubject had coronary intervention within 30 days prior to study procedureSubject has a coronary intervention planned within 30 days post procedureSubject has presence of left ventricular (LV) mural thrombusSubject has history of valve replacement or repair (e.g., MitraClipTM) including transcatheter edge to edge repair (TEER)Subject has significant mitral valve disease (defined as mitral regurgitation greater than moderate, grade ≥2+ by echocardiogram (ECHO), mitral stenosis with MVA <1.5 cm2) or has evidence of structural damage to the chordae tendineae or valveSubject has significant aortic valve disease (defined as aortic stenosis (valve area ≤1.5 cm2 or moderate or severe aortic regurgitation (grade ≥2+ by ECHO))Subject with atrial fibrillation present at the time of enrollment or any time prior to RHC or CSI pVAD device placementSubject has sustained tachycardia with heart rate over 120 BPMSubject has sustained ventricular tachycardia either pre- or during interventionSubject has severe pulmonary hypertension, defined as mean pulmonary artery pressure ≥40 mmHgSubject has presence of an aneurysm or dissection along vascular delivery path including:Abdominal aortic aneurysm 4.0 cm or greater, ORSignificant descending thoracic aortic aneurysm greater than 4.5 cm, ORAny dissection of the ascending, transverse, or descending aortaSubject has severe peripheral vascular disease that will preclude the use of a 12Fr access sheath, which is required for the insertion of the CSI pVAD catheterSubject has severe aortic tortuositySubject has severe aortic calcification that may preclude appropriate placement of the CSI pVAD deviceSubject's vasculature will not tolerate a right heart catheterization (RHC)Subject has chronic renal dysfunction defined by either:Serum creatinine ≥ 2.5 mg/dl AND/ORRequires hemodialysisSubject has liver dysfunction with either:Elevation of liver enzymes and bilirubin levels to ≥ 3X ULN ORInternationalized Normalized Ratio (INR) ≥ 2 ORLactate dehydrogenase (LDH) > 2.5X ULNSubject has uncorrectable abnormal coagulation parameters defined as either:Platelet count ≤75,000 per μL ORINR ≥2.0 orSubject has history of heparin induced thrombocytopeniaSubject has history of bleeding diathesis or known coagulopathy, any recent GU or GI bleed within 30 days prior to study procedure or will refuse blood transfusionsSubject has anemia (hemoglobin <10.0 g/dL) or polycythemia/hypovolemia (hemoglobin >16.5 g/dL)Subject requires, or, in the clinical judgement of the investigators may need, long term support (>6 hours) with a commercially available mechanical circulatory support (MCS) deviceSubject was on any mechanical cardiac support device at any time within 14 days prior to the study procedure.Subject has an active systemic infection requiring oral or intravenous antibiotics, or elevated temperature or white blood cell count that may be due to infectionSubject has been diagnosed with COVID ≤10 days prior to study procedure or is excluded due to COVID based on institution or other (e.g., CDC) guidelinesSubject has an allergy or intolerance to ionic and nonionic contrast media, anticoagulants, or antiplatelet therapy drugs that cannot be adequately premedicatedSubject has an allergy or intolerance to CSI pVAD System componentsSubject is pregnantSubject is currently participating or plans to participate in another investigational drug- or device trial that may affect any of this study's endpointsSubject has any other anatomical-, clinical-, social-, etc. characteristics that preclude the subject from being a candidate for the studySubject has any contradiction listed in the current IFU