Safety and Feasibility of the WhiteSwell System”

Inclusion Criteria:

Age >18
Subject is admitted to the hospital with a primary diagnosis of acute decompensated heart failure (ADHF).

Subjects receiving IV diuretic for ADHF and demonstrating fluid overload. This includes a minimum of 2 of the following:

peripheral edema ≥ +2 (on a 0 to +3 scale, indicating indentation of skin with mild digital pressure that requires 10 s or more to resolve in any dependent area including extremities or sacral region);
jugular venous distension ≥8 cm H2O
pulmonary edema or pleural effusion on chest radiograph
enlarged liver or ascites;
paroxysmal nocturnal dyspnea or ≥ two-pillow orthopnea;
dyspnea at rest with respiration rate ≥20 per minute
Renal function parameters: 30
Biomarkers: BNP/pro-BNP

BNP>400 pg/ml or NT-pro-BNP>1,600 pg/ml
For patients with rate-controlled persistent or permanent AF: BNP>600 pg/ml or NT-pro-BNP>2,400 pg/ml
Subject must be able to be enrolled into the trial ≤ 72 hours of their admission to the hospital
Subject agrees to comply with all follow-up evaluations
Subject has provided written informed consent; or if unable to perform informed consent, written informed consent on behalf of the subject has been provided by a legally-authorized representative

Exclusion Criteria:

Subjects requiring inotropic therapy, mechanical ventilation, or mechanical circulatory support
Subjects developing worsening renal function (creatinine >0.5 mg/dL above baseline) within the time frame from admission to enrollment.
Subject has experienced a thromboembolic event (eg, pulmonary embolism (PE), deep vein thrombosis (DVT)) within the previous 6 months
Subject has contraindications to systemic anticoagulation
Subject with INR >1.8 or on novel anticoagulants (NOACs). Subjects who have taken NOACs may be enrolled if a minimum of 48 hours has passed since their last dose, with the exception of subjects on Dabigatran, who may not be enrolled.
Subject has mechanical heart valve.
Subject with systolic blood pressure < 90mmHg at time of enrollment
Subject has evidence of active infection
Subject has anatomical abnormalities and variations, or visualization of the insertion and deployment site does not enable safe venous access and device deployment as assessed by ultrasound
Subject vein diameters proximal and distal to the internal jugular/subclavian vein bifurcation in area of device placement less than 13.5mm and/or greater than 205mm.
Subject has experienced transient ischemic attack (TIA) events or cerebrovascular events (CVA) at previous 6 months
Subject with Acute coronary syndrome (ACS).
Subject with severe concomitant disease expected to prolong hospitalization or expected to cause death in ≤ 90 days
Subject is pregnant. Pregnancy confirmed by positive urine or serum test, or lactating mothers