HeartMate PHP Cardiogenic Shock Pilot Trial

Recruiting

• Conditions: cardiogenic shock; weakened heart; 10082206

• Registration Number: NL-OMON43757
• Lead Sponsor: St. Jude Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1. 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 (average over 4 hours) OR increased creatinine of 0.3 mg/dl from baseline obtained within 2 weeks, OR cool extremities
2. Written, signed, and dated informed consent

Exclusion Criteria

1. Right ventricular failure requiring mechanical circulatory support
2. ST elevation myocardial infarction (STEMI) within 30 days of procedure
3. Cardiac arrest within 7 days of procedure requiring CPR
4. Current treatment with mechanical circulatory device such as IABP, ECMO, centrifugal pump, etc.
5. Documented acute myocarditis
6. Hypertrophic disease or any left ventricular outflow tract obstruction
7. Active sepsis defined as bacteremia, fever * 101.5 degrees F
8. Mural thrombus in the left ventricle
9. History of aortic valve replacement
10. End-stage renal disease requiring dialysis
11. Documented presence of aortic stenosis (orifice area of 1.5 cm2 or less)
12. Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as 2 or higher)
13. Platelet count < 100,000 x 109/L
14. Allergy or Intolerance to heparin, aspirin, clopidogrel, ionic and nonionic contrast media, or any other potentially required anticoagulants or antiplatelet therapy drugs
15. Known coagulopathies
16. Presence of risk factors for severe liver and/or renal dysfunction
17. Stroke within 90 days of enrollment
18. Significant peripheral vascular disease
19. History of heparin induced thrombocytopenia
20. Patient is pregnant or planning to become pregnant during the study period
21. Participation in another clinical study of an investigational drug or device that has not met its primary endpoint

Study & Design

• Study Type: Interventional
• Study Design: Not specified