Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2023
• Main ID: NCT02279979
• Date of registration: 29/10/2014
• Prospective Registration: No
• Primary sponsor: Abbott Medical Devices
• Public title: Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial
• Scientific title: Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial
• Date of first enrolment: October 2014
• Target sample size: 9
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT02279979
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria, Czech Republic, Czechia, Germany, Hungary, Netherlands, Slovenia

Contacts

• Name: Pooja Chatterjee
• Affiliation: Thoratec LLC, St. Jude Medical, Abbott

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cardiogenic Shock

Intervention(s)

Device: HeartMate PHP

Primary Outcome(s)

Clinical stabilization defined as improvement of Cardiac Index to > 2.2 L/min/m2 [Time Frame: 72 hours]

Secondary Outcome(s)

An assessment of major adverse events [Time Frame: 72 hours]

Secondary ID(s)

Thoratec HeartMate PHP™ CS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Thoratec Corporation