Tests a heart pressure monitor after cardiogenic shock hospital stays
Tests a small implanted sensor that tracks lung artery pressure in adults after cardiogenic shock.
Plain-language title generated from the registry record
Registry title: Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial
Key facts
- Where
- Falls Church, United StatesSee the site
Where in United States
- Inova Fairfax Medical CampusFalls Church, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Inova Health Care Services
- Trial code
- NCT04419480
- Record updated
- 16 March 2026
- Original description
Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic ShockRead full original descriptionShow less
Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial
Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock
Inclusion: 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; Patients must have internet and phone access (to allow communication of the implanted device with the researchers).
Exclusion: 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; Intolerance to or inability to adhere to antiplatelet therapy for 1 year after device implantation; Presence of an active, uncontrolled infection; Any condition other than heart failure that could limit survival to less than 6 months; Technical obstacles which pose an inordinately high procedural risk, in the judgment of the investigator; If of childbearing potential with a positive pregnancy test; Transition to hospice care; Discharge to facility other than acute rehabilitation or to the ambulatory setting; No access to internet or phone.