Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial

Cardiogenic Shock Clinical Trial

Official title:

Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02279979
• Other study ID #: Thoratec HeartMate PHP™ CS
• Status: Terminated
• Phase: N/A
• Start date: October 2014
• Est. completion date: January 2017

Study information

• Verified date: July 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Intervention

Device:
• HeartMate 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.

Locations

Country	Name	City	State
Czechia	Institute for Clinical and Experimental Medicine (IKEM)	Prague
Czechia	Na Homolce Hospital	Prague
Germany	Universitätskliniken Düsseldorf	Düsseldorf
Germany	Medizinische Hochschule Hannover	Hannover
Hungary	Semmelweis University Heart and Vascular Center	Budapest
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Medical Devices	Thoratec Corporation

Countries where clinical trial is conducted

Czechia,  Germany,  Hungary,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical stabilization defined as improvement of Cardiac Index to > 2.2 L/min/m2		72 hours
Secondary	An assessment of major adverse events		72 hours