The Safety and Feasibility of the eLym™ System

Korábbi kezelés

• Subjects requiring intravenous vasoactive therapies (e.g., vasodilators, inodilators, inotropes), mechanical ventilation, MCS, or ultrafiltration
• 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
• Subject currently on Dabigatran
• Previous intracranial bleed unless there is documentation that the patient can safely use anticoagulation for 3 days
• Inability to tolerate anticoagulation therapy for up to 3 days
• Subject with severe concomitant disease expected to prolong hospitalization or expected to cause death in ≤ 90 days

Más betegség

• Gastrointestinal (GI) bleeding within 6 months requiring hospitalization and/or transfusion.
• Recent major surgery within 30 days if the surgical would is judged to be associated with increased risk of bleeding.
• Subject has severe liver disease, liver fibrosis, or hempatorenal syndrome
• Subject has evidence of active blood stream infection or pneumonia
• Sustained malignant arrhythmias [e.g., ventricular tachycardia/fibrillation) in the last 90 days]
• Subject with acute coronary syndrome (ACS) in the last 3 months
• Subject with a rhythm management device implanted within the last 45 days (i.e., cardioverter/defibrillator, pacemaker, cardiac resynchronization device)

Laborértékek

• 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.
• Platelet count <75 10\^3/μL
• 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.

Egyéb

• Ultrasound Screening Assessment Exclusion:
  • Subjects' anatomy is not compatible with product dimensions as defined on the eLym system labelling
• Subject has contraindications to systemic anticoagulation
• Subject with systolic blood pressure <85 millimeters of mercury (mmHg) at time of enrollment
• Physician discretion

• Age ≥ 18 years
• Subject is admitted to the hospital with a primary diagnosis of Acute Decompensated Heart Failure (ADHF)
• 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 1 of the following:
  • Jugular venous distension ≥10 cm H20;
  • 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.
• Total DAILY diuretic dose prior to admission of ≥80mg Lasix or equivalent
• Renal function parameters as measured by estimated glomerular filtration rate (eGFR) ≥20 ml/min/1.73m2
• 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.
• 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).
• Albumin >2.5 g/dL
• 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
• Subject willing and able to complete study assessments and agrees to comply with all follow-up evaluations
• Subject has provided written informed consent