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Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02279979
Recruitment Status : Terminated
First Posted : October 31, 2014
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
Thoratec Corporation
Information provided by (Responsible Party):
Abbott Medical Devices

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.

Condition or disease Intervention/treatment Phase
Cardiogenic Shock Device: HeartMate PHP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial
Actual Study Start Date : October 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Treatment Arm
All enrolled patients will be treated with the HeartMate PHP device
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.




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

Secondary Outcome Measures :
  1. An assessment of major adverse events [ Time Frame: 72 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279979


Locations
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Czechia
Na Homolce Hospital
Prague, Czechia, 130 50
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia, 140 21
Germany
Universitätskliniken Düsseldorf
Düsseldorf, Germany, 40225
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Hungary
Semmelweis University Heart and Vascular Center
Budapest, Hungary, 1122
Netherlands
Erasmus Medical Center
Rotterdam, Netherlands, 3000-CA
Sponsors and Collaborators
Abbott Medical Devices
Thoratec Corporation
Investigators
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Study Director: Poornima Sood, MD, MBA Thoratec LLC, St. Jude Medical

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02279979     History of Changes
Other Study ID Numbers: Thoratec HeartMate PHP™ CS
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019

Keywords provided by Abbott Medical Devices:
PHP
Cardiogenic Shock
Percutaneous
Ventricular Assist
Heart Pump
Catheter
Thoratec Corporation

Additional relevant MeSH terms:
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Shock, Cardiogenic
Shock
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases