Hemodynamic monitoring to prevent Adverse events foLlowing cardiOgenic Shock (HALO Shock) Trial

Demonstrate that early implantation of a PA hemodynamic monitor is effective to reduce heart failure hospitalizations, and all-cause mortality, with improved health related quality of life following CS.

For more information, visit: https://clinicaltrials.gov/study/NCT04419480

Inova Health Care Services                                                                   
3300 Gallows Road                                                                                
Falls Church, VA 22042

• Patient has the capacity to participate in the study and complete the study questionnaires, in the estimation of the study investigator
• NYHA Class II-III symptoms at time of enrollment
• Survival to discharge for a recent hospital admission, or anticipated survival to discharge during a current hospital admission, with cardiogenic shock (CS) as defined by: Systolic blood pressure < 90 mmHg for > 30 minutes or requiring infusion of vasopressors and/or inotropes to maintain the systolic blood pressure above 90 mmHg and at least one of the following:
  • Evidence of end-organ dysfunction such as pulmonary edema or impaired endorgan perfusion including altered mentation, or
  • Oliguria with urine output < 30 mL/h, or serum lactate > 2 mmol/L, or
  • Hemodynamic criteria including cardiac index ≤ 1.8 L/min/m2 without vasoactive pharmacologic agents, or cardiac index ≤ 2.2 L/min/m2 and pulmonary artery occlusion pressure ≥ 15 mmHg with vasoactive agents
• Patients must have internet and phone access (to allow communication of the implanted device with the researchers, in the event of randomization to the treatment arm)

•  Technical obstacles which pose an inordinately high procedural risk, in the judgment of the investigator
•  Treatment with ongoing mechanical circulatory support (MCS) such as a durable left ventricular assist device (LVAD) or recipient of a heart transplant
•  If a woman of childbearing potential less than 50 years of age with a positive pregnancy test.
•  Intolerance to or inability to adhere to antiplatelet therapy for 1 month after device implantation.
•  Presence of an active, uncontrolled infection