Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial

Study Overview
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Brief Summary
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The primary objective of this study is to assess reasonable safety and performance of the HeartMate PHP to provide hemodynamic support for up to 72 hours in patients with cardiogenic shock requiring stabilization.

Detailed Description
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The HeartMate PHP is a catheter-based axial flow pump designed to provide partial left ventricular circulatory support. This prospective, nonrandomized, controlled, single-arm, multi-center, open-label trial will evaluate the safety and performance of the device in patients with cardiogenic shock.

Official Title
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Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial

Conditions
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Cardiogenic Shock

Intervention / Treatment
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* Device: HeartMate PHP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is indicated for left ventricular support according to current medical guidelines (current medical guidelines applies only to patients enrolled in Germany) Patient has a cardiac index of < 2.2 L/min/m2 and is being treated with at least one moderate dose inotrope or at least one moderate dose of vasopressor (e.g., milrinone ≥0.3 mcg/kg/min, dopamine > 5 mcg/kg/min, dobutamine > 5 mcg/kg/min) AND: PCWP > 18 mmHg, AND Systolic blood pressure < 100 mmHg, AND Decreased organ perfusion as evidenced by urine output of 50 mL/hr OR increased creatinine of 0.3 mg/dl from baseline obtained within 2 weeks, OR cool extremities Written, signed, and dated informed consent Exclusion Criteria: Patient is >85 years of age Right ventricular failure requiring mechanical circulatory support ST elevation myocardial infarction (STEMI) within 30 days of procedure Cardiac arrest within 7 days of procedure requiring CPR Current treatment with mechanical circulatory device such as IABP, ECMO, centrifugal pump, etc. Documented acute myocarditis Active major cardiac rhythm disturbances (e.g., ventricular tachycardia, ventricular fibrillation). Hypertrophic disease or any left ventricular outflow tract obstruction Active sepsis defined as bacteremia, fever ≥ 101.5 degrees F Mural thrombus in the left ventricle History of aortic valve replacement End-stage renal disease requiring dialysis 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) Platelet count < 100,000 Allergy or Intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs Known coagulopathies Presence of risk factors for severe liver and/or renal dysfunction Stroke within 90 days of enrollment Significant peripheral vascular disease History of heparin induced thrombocytopenia Patient is pregnant or planning to become pregnant during the study period Patient is breastfeeding. Any active disease (e.g., active cancer) which could affect the patient's participation in the study, or if life expectancy is less than 1 year. Any active disease in which the investigator determines would make the patient an inappropriate candidate for the study. 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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Maximum Age: 85 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: Treatment Arm<br>All enrolled patients will be treated with the HeartMate PHP device | Device: HeartMate PHP<br>* The HeartMate PHP system is a catheter-based heart pump and console designed to provide hemodynamic left ventricular support for up to 3 days to stabilize patients by maintaining adequate systemic cardiac output.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical stabilization defined as improvement of Cardiac Index to > 2.2 L/min/m2 |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An assessment of major adverse events |  | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PHP, Cardiogenic Shock, Percutaneous, Ventricular Assist, Heart Pump, Catheter, Thoratec Corporation