Clinical trial NCT05747196: The Safety and Feasibility of the eLym™ System
Official title: The Safety and Feasibility of the eLym™ System for the Decongestion of Excess Lymphatic Fluid Via the Thoracic Duct in Acute Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart; Decompensation, Congestive
Lead sponsor: WhiteSwell, Limited
Sponsor class: INDUSTRY
First posted: 2023-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study protocol indicates that subjects signing consent will be "enrolled"; however, the number of subjects treated with the investigational device will be less due to screening for inclusion / exclusion criteria.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this feasibility study is to evaluated the safety and performance of the WhiteSwell eLym System in the treatment of fluid overload or congestion in adult patients with Acute Decompensated Heart Failure (ADHF). The main question\[s\] it aims to answer are:

* Acute device safety (30 days)
* Chronic device safety (31-180 days)
* Primary performance Outcomes (Technical success and patient treatment outcomes)

Participants who are hospitalized for ADHF will be screened for treatment with the eLym System. The System, placed in a heart catheterization laboratory, will be temporarily placed for up to 72 hours to treat congestion. The patient will be followed during the hospital stay through discharge and have follow-up assessments at 30-, 90- and 180-days.


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

Primary outcomes:
measure: Acute safety as assessed by the rate of acute adjudicated device-, treatment-, and procedure-related Serious Adverse Events
timeFrame: Device placement skin puncture to 30 days post therapy
measure: Chronic safety as assessed by the rate of chronic adjudicated device-, treatment-, and procedure-related Serious Adverse Events (SAE)
timeFrame: Day 31 out to 180 days post therapy
measure: Technical system performance as measured by the rate of procedures that demonstrate the user's ability to deploy, activate and remove the system.
timeFrame: Device placement procedure through eLym System therapy end (therapy lasting less than or equal to 72 hours)
measure: Acute response to therapy as evaluated by changes in the patients' body weight
timeFrame: 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)
measure: Acute response to therapy as evaluated by changes in patients' net fluid loss or gain (milliliters)
timeFrame: 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)
measure: Acute response to therapy as evaluated by assessing changes in patients' renal function using estimated glomerular filtration rate (eGFR)
timeFrame: 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
measure: Acute response to therapy as evaluated by assessing changes in patients' renal function using laboratory parameter serum creatinine
timeFrame: 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
measure: Acute response to therapy as evaluated by the need for intensified heart failure therapy(ies) over the course of the hospitalization
timeFrame: Patient enrollment through hospital discharge (typically 3 - 10 days from admission to the hospital)
measure: Acute response to therapy as evaluated by assessing Extra Vascular Lung Water (EVLW) measured by Sensible Medical's ReDS technology.
timeFrame: Baseline (pre eLym System therapy) and post eLym System therapy (less than or equal to 72 hours after the initiation of therapy)
measure: Patient Quality of Life as evaluated by the Kansas City Quality of Life Questionnaire (KCCQ).
timeFrame: Baseline, Hospital discharge (typically 3- 10 days post hospital admission), 30-, 90-, and 180-days after hospital discharge.
measure: 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
timeFrame: Baseline and 30-, 90-, and 180-days after hospital discharge
measure: Long term patient outcomes as evaluated by the time (days) to rehospitalization for acute decompensated heart failure
timeFrame: Hospital discharge through 180 days post hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Israeli-Georgian Medical Research Clinical Helsicore
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Center
city: Tbilisi
country: Georgia
facility: Tbilisi Heart Centre
city: Wroclaw
country: Poland
facility: Wroclaw University Hospital and Clinics
city: Badalona
country: Spain
facility: Germans Trias i Pujol Hospital
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
Study officials:
affiliation: Ohio State University
name: William Abraham, MD
role: STUDY_DIRECTOR
References: