RecruitingNot ApplicableNCT04419480

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Sponsor

Inova Health Care Services

Enrollment

40 participants

Start Date

Dec 31, 2020

Study Type

INTERVENTIONAL

Conditions

Heart Failure Cardiogenic Shock Ambulatory Hemodynamic Monitoring

Summary

Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria9

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.
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
Discharge to facility other than acute rehabilitation or to the ambulatory setting.
No access to internet or phone.

Interventions

DEVICECardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization

Implantation of CardioMEMS Device in patients following admission for Cardiogenic shock, with regular ambulatory pulmonary artery pressure monitoring and medication optimization for the treatment of heart failure.