Clinical trial NCT02279979: Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial
Official title: Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiogenic Shock
Keywords: PHP
Cardiogenic Shock
Percutaneous
Ventricular Assist
Heart Pump
Catheter
Thoratec Corporation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Thoratec Corporation
First posted: 2014-10-31
Enrollment: 9
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical stabilization defined as improvement of Cardiac Index to > 2.2 L/min/m2
timeFrame: 72 hours
Secondary outcomes:
measure: An assessment of major adverse events
timeFrame: 72 hours
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine (IKEM)
city: Düsseldorf
country: Germany
facility: Universitätskliniken Düsseldorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Budapest
country: Hungary
facility: Semmelweis University Heart and Vascular Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Thoratec LLC, St. Jude Medical, Abbott
name: Pooja Chatterjee
role: STUDY_DIRECTOR
References: