The Safety and Feasibility of the eLym™ System for the Decongestion of Excess Lymphatic Fluid Via the Thoracic Duct in Acute Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 21
- 主要终点
- Acute safety as assessed by the rate of acute adjudicated device-, treatment-, and procedure-related Serious Adverse Events
研究概览
简要总结
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 60 hours to treat congestion. The patient will be followed during the hospital stay through discharge and have follow-up assessments at 30-, 60-, 90- and 180-days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Ultrasound Screening Assessment Exclusion:
- •Subjects' anatomy is not compatible with product dimensions as defined on the eLym system labelling
- •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 has contraindications to systemic anticoagulation
- •Subject currently on Dabigatran
- •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.
- •Previous intracranial bleed unless there is documentation that the patient can safely use anticoagulation for 3 days
- •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.
- •Platelet count <75 10^3/μL
- •Inability to tolerate anticoagulation therapy for up to 3 days
- •Subject with systolic blood pressure <85 millimeters of mercury (mmHg) at time of enrollment
- •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 severe concomitant disease expected to prolong hospitalization or expected to cause death in ≤ 90 days
- •Subject with a rhythm management device implanted within the last 45 days (i.e., cardioverter/defibrillator, pacemaker, cardiac resynchronization device)
- •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.
- •Physician discretion
结局指标
主要结局
Acute safety as assessed by the rate of acute adjudicated device-, treatment-, and procedure-related Serious Adverse Events
时间窗: Device placement skin puncture to 30 days post therapy
The rate of acute device-, treatment-, and procedure-related Serious Adverse Events (SAE) as adjudicated by an independent Clinical Events Committee will be reported.
Chronic safety as assessed by the rate of chronic adjudicated device-, treatment-, and procedure-related Serious Adverse Events (SAE)
时间窗: Day 31 out to 180 days post therapy
The rate of chronic device-, treatment-, and procedure-related Serious Adverse Events (SAE) as adjudicated by an independent Clinical Events Committee will be reported.
Acute response to therapy as evaluated by changes in patients' net fluid loss or gain (milliliters)
时间窗: 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)
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.
Acute response to therapy as evaluated by assessing changes in patients' renal function using laboratory parameter serum creatinine
时间窗: 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
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.
Acute response to therapy as evaluated by the need for intensified heart failure therapy(ies) over the course of the hospitalization
时间窗: Patient enrollment through hospital discharge (typically 3 - 10 days from admission to the hospital)
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.
Technical system performance as measured by the rate of procedures that demonstrate the user's ability to deploy, activate and remove the system.
时间窗: Device placement procedure through eLym System therapy end (therapy lasting less than or equal to 72 hours)
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.
Acute response to therapy as evaluated by assessing changes in patients' renal function using estimated glomerular filtration rate (eGFR)
时间窗: 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
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.
Acute response to therapy as evaluated by changes in the patients' body weight
时间窗: 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)
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.
Long term patient outcomes as evaluated by the time (days) to rehospitalization for acute decompensated heart failure
时间窗: Hospital discharge through 180 days post hospital discharge
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.
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
时间窗: Baseline and 30-, 90-, and 180-days after hospital discharge
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.
Acute response to therapy as evaluated by assessing Extra Vascular Lung Water (EVLW) measured by Sensible Medical's ReDS technology.
时间窗: Baseline (pre eLym System therapy) and post eLym System therapy (less than or equal to 72 hours after the initiation of therapy)
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).
Patient Quality of Life as evaluated by the Kansas City Quality of Life Questionnaire (KCCQ).
时间窗: Baseline, Hospital discharge (typically 3- 10 days post hospital admission), 30-, 90-, and 180-days after hospital discharge.
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.
次要结局
未报告次要终点