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

Prior treatment

• Implanted left ventricular assist device (LVAD) or implant anticipated in \<3 months

Other illness

• Subject considered to be in the acute worsening of heart failure: Requiring invasive or non-invasive mechanical ventilation, mechanical circulatory support or is clinically unstable requiring pressors, inotropes, deterioration triggered by arrhythmia, infection, or other medical condition unrelated to fluid overload .
• Subject has any known or visible lower body (non-facial) skin condition (open wounds, ulcers, infections) that can potentially prevent using the wearable for the duration of the procedure
• Known allergy to Polyester or Thermoplastic polyurethane (TPU)
• Subject with severe peripheral arterial disease
• Subject with known hypothalamic disorders
• Subject with known hypohidrosis disorders
• Subject with active infections
• History of a heart transplant or actively listed for a heart transplant
• Subject with a life expectancy of less than 6 months, per investigator's discretion, due to malignant or non-cardiac comorbidities

Other

• Subject is pregnant or planning to become pregnant within the study period, or a lactating woman.
• Subjects with external medical technology dependency (gastric (G) tubes, ventilators, peripherally inserted central venous catheters, etc.)
• Subject with cystic fibrosis
• Inability or unwillingness to comply with the study requirements
• Subjects with unstable electrolytes or acid-base balance (as per investigator's discretion)
• Known Severe aortic valve or mitral valve stenosis

• Age ≥21 years and \< 80 years
• Subject, with known decompensated heart failure NYHA Class II, III (as evaluated by an independent observer who is not on the study team) presenting with fluid overload, defined by a congestion score of ≥3, who are not responding adequately or are resistant to current medical treatment as evidenced by persistent or worsening congestion, despite a daily dose of 80 mg furosemide or greater or the equivalent dose of another loop diuretic .
• No change in diuretic dosage in the past 5 days
• Subjects with eGFR between 15-89 mL/min/1.73m2
• Baseline NT-proBNP ≥600 pg/mL
• Baseline systolic blood pressure ≥100 mmHg
• Subject is able and willing to provide written informed consent, inclusive of the release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation
• Subject is not participating in any clinical investigation that may interfere with the data collection or the results of this study