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Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial

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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

Tracking Information
First Submitted Date  ICMJE October 29, 2014
First Posted Date  ICMJE October 31, 2014
Last Update Posted Date February 4, 2019
Actual Study Start Date  ICMJE October 2014
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2014)
Clinical stabilization defined as improvement of Cardiac Index to > 2.2 L/min/m2 [ Time Frame: 72 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02279979 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2014)
An assessment of major adverse events [ Time Frame: 72 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial
Official Title  ICMJE Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cardiogenic Shock
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Treatment Arm
All enrolled patients will be treated with the HeartMate PHP device
Intervention: Device: HeartMate PHP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 16, 2017)
9
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2014)
25
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 85 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Germany,   Hungary,   Netherlands
Removed Location Countries Austria,   Czech Republic,   Slovenia
 
Administrative Information
NCT Number  ICMJE NCT02279979
Other Study ID Numbers  ICMJE Thoratec HeartMate PHP™ CS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Thoratec Corporation
Investigators  ICMJE
Study Director: Poornima Sood, MD, MBA Thoratec LLC, St. Jude Medical
PRS Account Abbott Medical Devices
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP