Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System

Inclusion Criteria:

• Age ≥21 years and < 80 years

• Patient, with known decompensated heart failure and/or CKD stage 2 or morepresenting with fluid overload, defined by a congestion score of ≥3, who are notresponding adequately or are resistant to current medical treatment as evidenced bypersistent or worsening congestion, despite a daily dose of 40 mg furosemide orgreater or the equivalent dose of another loop diuretic.

• Patients with no Heart Failure related hospitalization in the past 30 days

• No change in diuretic regimen in the past 7 days

• Baseline NT-proBNP ≥600 pg/mL

• Baseline systolic blood pressure ≥100 mmHg

• Patient is able and willing to provide written informed consent, inclusive of therelease of medical information, and Health Insurance Portability and AccountabilityAct (HIPAA) documentation

• Patient is not participating in any clinical investigation that may interfere withthe data collection or the results of this study

Exclusion Criteria:

• Patient considered to be in the acute worsening of heart failure: Requiringventilation, mechanical support or is clinically unstable requiring pressors,deterioration triggered by arrhythmia, infection, or other medical conditionunrelated to fluid overload.

• Patient has any known or visible lower body (non-facial) skin problems (open wounds,ulcers, infections)

• Patient with severe peripheral arterial disease

• Patient is pregnant or planning to become pregnant within the study period, or alactating woman.

• Renal disease with eGFR <25 ml/min/1.73 m2

• Patients with known hypothalamic disorders

• Patients with known hypohidrosis disorders

• Patients with medical technology dependency (gastric (G) tubes, ventilators etc.)

• Patients with cystic fibrosis

• Patients with active infections

• Inability or unwillingness to comply with the study requirements

• Patients with unstable electrolytes or acid-base balance (per investigator'sdiscretion)

• Known Severe aortic valve or mitral valve stenosis

• History of a heart transplant or actively listed for a heart transplant or LVAD

• Implanted left ventricular assist device or implant anticipated <3 months

• Patients with an active, malignant disease and whose life expectancy is < 6 months (per investigator's discretion)

• Unstable or acutely worsening cardiac or renal conditions (per investigator'sdiscretion)