About this trial
Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock
Eligibility criteria
Qualifiers
Subject or legal representative has signed Informed Consent Form (ICF) and the patient has the capacity to participate in the study and complete the study questionnaires, in the estimation of the study investigator.
Age ≥ 18 years
NYHA Class III with dyspnea upon mild physical activity, regardless of left ventricular ejection fraction (LVEF).
Survive to discharge during a current hospital admission with cardiogenic shock (CS) as defined by clinical criteria previously used in cardiogenic shock trials: systolic blood pressure < 90 mmHg for > 30 minutes or requiring infusion of catecholamines to maintain the systolic blood pressure above 90 mmHg, with evidence of end-organ dysfunction such as pulmonary edema or impaired end-organ perfusion including altered mentation, oliguria with urine output < 30 mL/h, or serum lactate > 2 mmol/L (5). Hemodynamic criteria include 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.
Disqualifiers
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 transplantation for the treatment of cardiogenic shock during the index hospitalization for CS.
If of childbearing potential with a positive pregnancy test.
Transition to hospice care.
Trial design
Treatments tested in this trial
- CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization
Treatment groups
Sponsors and collaborators
Inova Health Care Services
Lead sponsor
Abbott
Collaborator