Status:
TERMINATED
Thoratec Corporation HeartMate PHP™ Cardiogenic Shock Trial
Lead Sponsor:
Abbott Medical Devices
Collaborating Sponsors:
Thoratec Corporation
Conditions:
Cardiogenic Shock
Eligibility:
All Genders
Up to 85 years
Phase:
NA
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 s...
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-labe...
Eligibility Criteria
Inclusion
- Patient is indicated for left ventricular support according to current medical guidelines ("current medical guidelines" applies only to patients enrolled in Germany)
- 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
- Written, signed, and dated informed consent
Exclusion
- Patient is \>85 years of age
- Right ventricular failure requiring mechanical circulatory support
- ST elevation myocardial infarction (STEMI) within 30 days of procedure
- Cardiac arrest within 7 days of procedure requiring CPR
- Current treatment with mechanical circulatory device such as IABP, ECMO, centrifugal pump, etc.
- Documented acute myocarditis
- Active major cardiac rhythm disturbances (e.g., ventricular tachycardia, ventricular fibrillation).
- Hypertrophic disease or any left ventricular outflow tract obstruction
- Active sepsis defined as bacteremia, fever ≥ 101.5 degrees F
- Mural thrombus in the left ventricle
- History of aortic valve replacement
- End-stage renal disease requiring dialysis
- Documented presence of aortic stenosis (orifice area of 1.5 cm2 or less)
- Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher)
- Platelet count \< 100,000
- Allergy or Intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs
- Known coagulopathies
- Presence of risk factors for severe liver and/or renal dysfunction
- Stroke within 90 days of enrollment
- Significant peripheral vascular disease
- History of heparin induced thrombocytopenia
- Patient is pregnant or planning to become pregnant during the study period
- Patient is breastfeeding.
- 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.
- Any active disease in which the investigator determines would make the patient an inappropriate candidate for the study.
- Participation in another clinical study of an investigational drug or device that has not met its primary endpoint
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02279979
Start Date
October 1 2014
End Date
January 1 2017
Last Update
July 21 2023
Active Locations (6)
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1
Na Homolce Hospital
Prague, Czechia, 130 50
2
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia, 140 21
3
Universitätskliniken Düsseldorf
Düsseldorf, Germany, 40225
4
Medizinische Hochschule Hannover
Hanover, Germany, 30625