HeartMate PHP CE Mark Clinical Investigatio

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- At least 18 years of age.
- Patient presents with a non-emergent need for complex PCI with:
1) an ejection fraction of <=35% requiring hemodynamic support during the procedure,
AND
2) the heart team has determined that the patient is not an optimal surgical candidate, OR the patient elects not to undergo surgery
- Written, signed, and dated informed consent

Exclusion Criteria

- Emergent PCI
- ST elevation myocardial infarction within 7 days of procedure
- Cardiac arrest within 7 days of procedure requiring CPR or defibrillation
- Hemodynamic support with the HeartMate PHP post-PCI is anticipated
- Cardiogenic shock (SBP <90 mmHg for >1 hour with either cool clammy skin OR oliguria OR altered sensorium OR cardiac index <2.2 L/min/m2)
- Mural thrombus in the left ventricle
- History of aortic valve replacement
- Documented presence of aortic stenosis (orifice area of 1.5 cm2 or less)
- Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher )
- Severe peripheral vascular disease
- Abnormalities of the aorta that would preclude surgery, including aneurysms and significant tortuosity or calcifications
- Planned use of rotablator or atherectomy during the procedure
- Serum creatinine > 3.5mg/dL within 7 days of procedure
- Liver dysfunction with elevation of liver enzymes and bilirubin levels to >= 3x ULN or INR (Internationalized Normalized Ratio) >= 2
- Uncorrectable abnormal coagulation parameters
- Active systemic infection requiring treatment with antibiotics
- Clinically relevant stroke or TIA within 3 months of procedure. Patients with suspected stroke or TIA within 3 months of procedure must have documented absence of neurological infarction
- Uncontrollable allergy or intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs
- History of heparin induced thrombocytopenia.
- Patient is pregnant or planning to become pregnant during the study period
- Participation in another clinical study of an investigational drug or device that has not met its primary endpoint

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Freedom from hemodynamic compromise during PCI procedure defined as: Mean<br /><br>Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes<br /><br>during the PCI procedure and additional pressor medication is not required.<br /><br><br /><br>Primary Safety Endpoint:<br /><br>Composite of Major Adverse Events (MAE):<br /><br>* device-related cardiac death,<br /><br>* new Q wave myocardial infarction,<br /><br>* surgical intervention due to device complication or malfunction,<br /><br>* device-related access site complication requiring intervention or<br /><br>device-related limb ischemia,<br /><br>* cerebral vascular accident (CVA),<br /><br>* new or worsening aortic valve insufficiency,<br /><br>* major bleeding complication (BARC 3 or >),<br /><br>* severe hypotension<br /><br><br /><br>Primary Endpoint will be evaluated at:<br /><br>* Post procedure or at hospital discharge (whichever is longer)<br /><br>* 30 days post procedure</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Efficacy of hemodynamic support as measured by:<br /><br>* Maximal decrease in cardiac power output (CPO) from baseline<br /><br>* Changes in central venous pressure from baseline (CVP)<br /><br>* Changes in pulmonary artery pressure from baseline (PAP)<br /><br>* Changes in pulmonary capillary wedge pressure from baseline (PCWP)<br /><br>* Changes in cardiac output from baseline (CO)<br /><br>* Changes in cardiac index from baseline (CI)<br /><br>2) Individual components of the Major Adverse Event Composites<br /><br><br /><br>Secondary Endpoints will be evaluated at:<br /><br>* Post procedure or at hospital discharge (whichever is longer)<br /><br>* 30 days post procedure</p><br>