HeartMate PHP™ CE Mark Clinical Investigation Plan

Study Overview
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Brief Summary
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The HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. The study will assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI), such as coronary stent placement.

Detailed Description
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The HeartMate PHP (percutaneous heart pump) is a catheter-based axial flow pump designed to provide partial left ventricular circulatory support. The primary objective of this prospective, nonrandomized, multi-center, open-label trial is to assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI).

Official Title
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HeartMate PHP™ CE Mark Clinical Investigation Plan

Conditions
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High Risk Percutaneous Coronary Intervention

Intervention / Treatment
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* Device: Percutaneous ventricular support with the HeartMate PHP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age. Patient presents with a non-emergent need for complex PCI with: an ejection fraction of ≤35% requiring hemodynamic support during the procedure, AND 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 1.5cm2 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-

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous coronary intervention<br>Percutaneous ventricular support with the HeartMate PHP during high risk percutaneous coronary intervention | Device: Percutaneous ventricular support with the HeartMate PHP<br>* The HeartMate PHP device will be inserted percutaneously prior to the start of high risk coronary interventions (complex disease, reduced ejection fraction, etc.) to provide hemodynamic support,<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoint | Efficacy of hemodynamic support as measured by: Maximal decrease in cardiac power output (CPO) from baseline Changes in central venous pressure from baseline (CVP) Changes in pulmonary artery pressure from baseline (PAP) Changes in pulmonary capillary wedge pressure from baseline (PCWP) Changes in cardiac output from baseline (CO) Changes in cardiac index from baseline (CI) | Post procedure or at hospital discharge (whichever is longer), 30 days post procedure | 
| Major Adverse Event Composites | Individual components of the major adverse event composites | Post procedure or at hospital discharge (whichever is longer), 30 days post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HeartMate PHP, HeartMate PHP CE Mark, Percutaneous coronary intervention, PCI, Percutaneous ventricular assist, Thoratec Corporation