Evaluation of FlowMod System While Intermittently Partially Occluding Vena Cava Blood Flow in Subjects With ADHF

Urinary spot sodium (3 hours after start of therapy)

Urinary sodium concentration measured in a spot urine sample

Time frame: 3 hours after start of therapy

Weight loss

Change in subject body weight from baseline to protocol-specified post-treatment timepoints

Time frame: From baseline through study completion, an average of 90 days

Time to discharge readiness

Time until the subject is considered clinically ready for safe discharge according to institutional criteria and treating physician assessment.

Time frame: From post-procedure to index discharge, an average of 24 hours

Index admission hemodialysis or continued renal replacement therapy

Occurrence of hemodialysis or continued renal replacement therapy during the index hospitalization following FlowMod therapy.

Time frame: Periprocedural hemodialysis, an average of 24 hours

Hemodialysis post discharge through 90 days post discharge

Occurrence of hemodialysis after index hospital discharge

Time frame: Through 90 days after index discharge

Modified Borg Dyspnea change from baseline, at 12 hours during therapy and post device removal

Change in patient-reported dyspnea severity from baseline, measured using the Modified Borg Dyspnea scale at 12 hours during therapy and after device removal

Time frame: Baseline to 12 hours during therapy and post device removal

Diuretic efficiency changes from baseline, at 12 hours during therapy and post device removal

Diuretic efficiency assessed by urinary output measured in milliliters (mL)

Time frame: At 12 hours and post device removal, an average of 24 hours

EQ5D change from baseline at discharge, 30 and 90 days

Change from baseline in EQ-5D score, a standardized measure of health-related quality of life across mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with self-rated overall health status, assessed at hospital discharge, 30 days, and 90 days.

Time frame: EQ5D from Baseline at discharge, (an average of 24 hours) and at 30 days and 90 days

eGFR change from baseline and at 24 hours after initiation of therapy or hospital discharge, whichever comes first

Change from baseline in estimated glomerular filtration rate (eGFR), calculated based on serum creatinine and used to evaluate renal function, assessed at 24 hours after initiation of FlowMod therapy or at hospital discharge, whichever occurs first.

Time frame: Baseline to 24 hours after initiation of therapy or hospital discharge, whichever occurs first

Cystatin C changes from baseline and at 24 hours after initiation of therapy or hospital discharge, whichever comes first

Change from baseline in Cystatin C, a blood biomarker used to assess kidney function and evaluate changes over time, assessed at 24 hours after initiation of FlowMod therapy or at hospital discharge, whichever occurs first

Time frame: Baseline to 24 hours after initiation of therapy or hospital discharge, whichever occurs first

Right atrial, pulmonary artery, PCWP and cardiac output changes from baseline, at 8 hours during therapy and end of therapy

Change from baseline in invasive hemodynamic parameters, including right atrial pressure, pulmonary artery pressure, pulmonary capillary wedge pressure, and cardiac output, assessed at 8 hours during FlowMod therapy and at end of therapy.

Time frame: Baseline, 8 hours during therapy, and end of therapy