The Safety and Feasibility of the eLym™ System

Acute safety as assessed by the rate of acute adjudicated device-, treatment-, and procedure-related Serious Adverse Events

The rate of acute device-, treatment-, and procedure-related Serious Adverse Events (SAE) as adjudicated by an independent Clinical Events Committee will be reported.

Time frame: Device placement skin puncture to 30 days post therapy

Chronic safety as assessed by the rate of chronic adjudicated device-, treatment-, and procedure-related Serious Adverse Events (SAE)

The rate of chronic device-, treatment-, and procedure-related Serious Adverse Events (SAE) as adjudicated by an independent Clinical Events Committee will be reported.

Time frame: Day 31 out to 180 days post therapy

Technical system performance as measured by the rate of procedures that demonstrate the user's ability to deploy, activate and remove the system.

The system's technical performance will be assessed by evaluating the rate of procedures in which the user is able to deploy, activate and remove the system.

Time frame: Device placement procedure through eLym System therapy end (therapy lasting less than or equal to 72 hours)

Acute response to therapy as evaluated by changes in the patients' body weight

Patients' acute response to therapy will be evaluated by assessing changes in body weight as measured in kilograms at baseline (prior to eLym therapy), after eLym therapy (less than or equal to 72 hours after therapy initiation) and at discharge from the hospital (expected 3 - 10 days after hospital admission). The change in weight will be expressed as an absolute change and percent change with an expected decrease corresponding to a treatment response.

Time frame: Baseline (prior to eLym therapy), after eLym therapy (less than or equal to 72 hours after therapy initiation) and at discharge from the hospital (expected 3 - 10 days after hospital admission)

Acute response to therapy as evaluated by changes in patients' net fluid loss or gain (milliliters)

Patients' acute response to therapy will be evaluated by assessing changes in patients' net fluid loss or gain based in total intake and output over 24 hours and expressed in milliliters at baseline (prior to eLym therapy), after eLym therapy (less than or equal to 72 hours after therapy initiation) and at discharge from the hospital (expected 3 - 10 days after hospital admission). An expected net fluid loss would correspond to a treatment response.

Time frame: Baseline (prior to eLym therapy), after eLym therapy (less than or equal to 72 hours after therapy initiation) and at discharge from the hospital (expected 3 - 10 days after hospital admission)

Acute response to therapy as evaluated by assessing changes in patients' renal function using estimated glomerular filtration rate (eGFR)

Patients' acute response to therapy will be evaluated by assessing changes in renal function as measured by estimated glomerular filtration rate (eGFR) (ml/min/1.73 (2)) using the Modification of Diet in Renal Disease (MDRD) calculation. Stable renal function would indicate a neutral response to therapy.

Time frame: Baseline (prior to eLym therapy), after eLym therapy (less than or equal to 72 hours after therapy initiation), discharge from the hospital (expected 3 - 10 days after hospital admission), and at 30 day follow-up

Acute response to therapy as evaluated by assessing changes in patients' renal function using laboratory parameter serum creatinine

Patients' acute response to therapy will be evaluated by assessing changes in renal function as measured by changes in serum creatinine (mg/dL). Stable renal function would indicate a neutral response to therapy.

Time frame: Baseline (prior to eLym therapy), after eLym therapy (less than or equal to 72 hours after therapy initiation), discharge from the hospital (expected 3 - 10 days after hospital admission), and at 30 day follow-up

Acute response to therapy as evaluated by the need for intensified heart failure therapy(ies) over the course of the hospitalization

Patients' acute response to therapy will be evaluated by assessing the need for intensified heart failure therapies indicating a worsening of the patient's condition, specifically evaluating the use of mechanical circulatory support, intravenous inotropes, or intravenous venodilators.

Time frame: Patient enrollment through hospital discharge (typically 3 - 10 days from admission to the hospital)

Acute response to therapy as evaluated by assessing Extra Vascular Lung Water (EVLW) measured by Sensible Medical's ReDS technology.

Patients' acute response to therapy will be evaluated by assessing Extra Vascular Lung Water (EVLW) as measured by Sensible Medical ReDS technology. The digital readout is provide as percent (%) with increasing numbers indicating a higher percentage of lung water and more congestion. Normal is consider to be less than 30%. Assessments will be made on seated patients prior to and just after the completion of therapy (less than or equal to 72 hours after the initiation of therapy).

Time frame: Baseline (pre eLym System therapy) and post eLym System therapy (less than or equal to 72 hours after the initiation of therapy)

Patient Quality of Life as evaluated by the Kansas City Quality of Life Questionnaire (KCCQ).

Changes in patients' quality of life will be assessed based on responses to the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. All items are measured on a Likert scale with 5-7 response options. All KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent. The scale will be administered at baseline, hospital discharge, and 30- 90- and 180- days post discharge.

Time frame: Baseline, Hospital discharge (typically 3- 10 days post hospital admission), 30-, 90-, and 180-days after hospital discharge.

Chronic response to therapy as evaluated by assessing changes in N Terminal-Pro Brain Natriuretic Peptide (NT-ProBNP) or Brain Natriuretic Peptide (BNP) biomarker levels

Changes in N Terminal Pro Brain Natriuretic Peptide in picograms/milliliter (pg/ml) (NT-ProBNP) or Brain Naturiretic Peptide picograms/milliliter (pg/ml)(BNP) will assessed to evaluate the patient heart failure status at baseline, 30-, 90- and 180- days. NT-ProBNP or BNP increases are noted with increased patient congestion. A reduction in NT-ProBNP or BNP would indicate a patient improvement. Changes in NT-ProBNP or BNP will be expressed as an absolute change and a percent change from baseline.

Time frame: Baseline and 30-, 90-, and 180-days after hospital discharge

Long term patient outcomes as evaluated by the time (days) to rehospitalization for acute decompensated heart failure

Patients' need for rehospitalization for acute decompensated heart failure will be reported as observed starting at hospital discharge post therapy through the 180-day follow up window. An independent clinical events committee will adjudicate hospitalizations for heart failure relatedness.

Time frame: Hospital discharge through 180 days post hospital discharge