Cardiogenic Shock
Conditions
Keywords
PHP, Cardiogenic Shock, Percutaneous, Ventricular Assist, Heart Pump, Catheter, Thoratec Corporation
Brief summary
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
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.
Interventions
DEVICEHeartMate PHP
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.
Sponsors
Thoratec Corporation
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patient is indicated for left ventricular support according to current medical guidelines (current medical guidelines applies only to patients enrolled in Germany) 2. 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 3. Written, signed, and dated informed consent
Exclusion criteria
1. Patient is \>85 years of age 2. Right ventricular failure requiring mechanical circulatory support 3. ST elevation myocardial infarction (STEMI) within 30 days of procedure 4. Cardiac arrest within 7 days of procedure requiring CPR 5. Current treatment with mechanical circulatory device such as IABP, ECMO, centrifugal pump, etc. 6. Documented acute myocarditis 7. Active major cardiac rhythm disturbances (e.g., ventricular tachycardia, ventricular fibrillation). 8. Hypertrophic disease or any left ventricular outflow tract obstruction 9. Active sepsis defined as bacteremia, fever ≥ 101.5 degrees F 10. Mural thrombus in the left ventricle 11. History of aortic valve replacement 12. End-stage renal disease requiring dialysis 13. Documented presence of aortic stenosis (orifice area of 1.5 cm2 or less) 14. Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher) 15. Platelet count \< 100,000 16. Allergy or Intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs 17. Known coagulopathies 18. Presence of risk factors for severe liver and/or renal dysfunction 19. Stroke within 90 days of enrollment 20. Significant peripheral vascular disease 21. History of heparin induced thrombocytopenia 22. Patient is pregnant or planning to become pregnant during the study period 23. Patient is breastfeeding. 24. 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. 25. Any active disease in which the investigator determines would make the patient an inappropriate candidate for the study. 26. Participation in another clinical study of an investigational drug or device that has not met its primary endpoint
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical stabilization defined as improvement of Cardiac Index to > 2.2 L/min/m2 | 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| An assessment of major adverse events | 72 hours |
Countries
Czechia, Germany, Hungary, Netherlands
Outcome results
None listed