The Safety and Feasibility of the eLym™ System

Launched by WHITESWELL, LIMITED · Feb 24, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called the eLym™ System, which aims to help patients with Acute Decompensated Heart Failure (ADHF) who are experiencing fluid overload. The study will assess how safe this system is over a short period (30 days) and a longer period (up to 180 days). To participate, patients should be at least 18 years old and currently hospitalized for ADHF, showing signs of fluid buildup. Important signs include swelling in the legs, difficulty breathing, or rapid weight gain due to fluid retention. Participants will have the device temporarily placed in a specialized heart procedure room for up to 72 hours and will be closely monitored during their hospital stay and for follow-up visits after discharge.

Eligible participants will be those who are already receiving certain medications to help remove excess fluid, and who meet other health criteria determined by the study team. If you or a loved one are facing issues with fluid overload due to heart failure, this study may provide access to a new treatment option while contributing to important medical research. It's essential for participants to agree to follow-up appointments and to provide written consent for their involvement in the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years
• • 2. Subject is admitted to the hospital with a primary diagnosis of Acute Decompensated Heart Failure (ADHF)
• 3. Subjects receiving intravenous (IV) diuretic for decompensated heart failure and demonstrating fluid overload. This includes peripheral edema ≥2+ (on a 0 to 4+ scale) and a minimum of 2 of the following:
• • Jugular venous distension ≥10 cm water;
• • Pulmonary edema as determined by auscultation or imaging;
• • Hepatojugular reflux;
• • Paroxysmal nocturnal dyspnea or ≥ two-pillow orthopnea;
• • Dyspnea at rest with respiration rate ≥20 per minute.
• • 4. Total DAILY diuretic dose prior to admission of ≥80mg Lasix or equivalent
• • 5. Renal function parameters as measured by estimated glomerular filtration rate (eGFR) ≥20 ml/min/1.73m2
• 6. Subject must meet on one of the following criteria:
• • Subject has had a heart failure hospitalization or worsening of heart failure event requiring IV diuretic therapy (in hospital, emergency room, urgent care, or HF clinic) within the previous 6 months;
• • Renal function as measured by eGFR ≥20 and ≤45 ml/min/1.73m2;
• • At initial HF admission, \<600 ml of urine output within 6 hours of initial IV bolus or urine sodium of \<50 mmol/L at 1-2 hours after initial IV diuretic dose.
• 7. Elevated N-Terminal (NT) Pro B-type Natriuretic Peptide (BNP) or BNP:
• • NT Pro BNP \>1000 pg/ml (\>1500 for subjects with atrial fibrillation);
• • BNP \>250 pg/ml (\>375 for subjects with atrial fibrillation).
• • 8. Albumin \>2.5 g/dL
• • 9. Subject must be able to have device placement procedure within 96 hours of presentation to the hospital and still be demonstrating fluid overload at the time of device placement
• • 10. Subject willing and able to complete study assessments and agrees to comply with all follow-up evaluations
• • 11. Subject has provided written informed consent
• Exclusion Criteria:
• 1. Ultrasound Screening Assessment Exclusion:
• • Subjects have anatomical abnormalities that would affect the insertion and deployment of the eLym System
• * Subject has vein diameters at anticipated sites of deployment balloons that are not within the following specifications:
• • Proximal restriction balloon site must have a venous diameter of 8 - 18 millimeters (mm)
• • Distal balloon site must have a diameter of 12 - 20 mm
• • 2. Subjects requiring intravenous vasoactive therapies (e.g., vasodilators, inodilators, inotropes), mechanical ventilation, MCS, or ultrafiltration
• • 3. Subject has experienced a thromboembolic event \[e.g., pulmonary embolism (PE), deep vein thrombosis (DVT), transient ischemic attack (TIA), or cerebrovascular events (CVA)\] within the previous 6 months
• • 4. Subject has contraindications to systemic anticoagulation
• • 5. Subject currently on Dabigatran
• • 6. Subject with International Normalized Ratio (INR) \>2.2 not due to anticoagulation therapy, hypercoagulable state including heparin-induced thrombocytopenia, or on novel anticoagulants (NOACs) that cannot be held for a minimum of 24 hours prior to eLym System placement Note: If subject's INR is \>2.2 at the screening and baseline assessment, it may be repeated to assess eligibility up to the time of the procedure.
• • 7. Previous intracranial bleed unless there is documentation that the patient can safely use anticoagulation for 3 days
• • 8. Gastrointestinal (GI) bleeding within 6 months requiring hospitalization and/or transfusion.
• • 9. Recent major surgery within 30 days if the surgical would is judged to be associated with increased risk of bleeding.
• • 10. Platelet count \<75 10\^3/μL
• • 11. Inability to tolerate anticoagulation therapy for up to 3 days
• • 12. Subject with systolic blood pressure \<85 millimeters of mercury (mmHg) at time of enrollment
• • 13. Subject has severe liver disease, liver fibrosis, or hempatorenal syndrome
• • 14. Subject has evidence of active blood stream infection or pneumonia
• • 15. Sustained malignant arrhythmias \[e.g., ventricular tachycardia/fibrillation) in the last 90 days\]
• • 16. Subject with acute coronary syndrome (ACS) in the last 3 months
• • 17. Subject with severe concomitant disease expected to prolong hospitalization or expected to cause death in ≤ 90 days
• • 18. Subject with a rhythm management device implanted within the last 45 days (i.e., cardioverter/defibrillator, pacemaker, cardiac resynchronization device)
• • 19. Subject is pregnant or lactating. Women of childbearing age who are not post-menopausal or not surgically sterile will need to demonstrate a negative urine or serum test.
• • 20. Physician discretion