BridgeMD
Tests treatment safety and results for Heart; Decompensation, Congestive
Official title The Safety and Feasibility of the eLym™ System
ClinicalTrials.gov ID: NCT05747196
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Subject is admitted to the hospital with a primary diagnosis of Acute Decompensated Heart Failure (ADHF)
- people receiving intravenous (IV) diuretic for decompensated heart failure and demonstrating fluid overload. This includes peripheral edema ≥2+ (on a...
- Jugular venous distension ≥10 cm H20;
- Pulmonary edema as determined by auscultation or imaging;
You likely can't join if
- Ultrasound Screening Assessment Exclusion:
- people' anatomy is not compatible with product dimensions as defined on the eLym system labelling
- people 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...
- Subject has contraindications to systemic anticoagulation
- Subject currently on Dabigatran
See the full eligibility criteria
- Age ≥ 18 years
- Subject is admitted to the hospital with a primary diagnosis of Acute Decompensated Heart Failure (ADHF)
- people 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 people with atrial fibrillation);
- BNP \>250 pg/ml (\>375 for people 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
- Ultrasound Screening Assessment Exclusion:
- people' anatomy is not compatible with product dimensions as defined on the eLym system labelling
- people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tbilisi, Georgia, Georgia
- Wroclaw, Poland
- Barcelona, Spain, Spain
- Badalona, Spain
- Madrid, Spain
- Majadahonda, Spain
- San Carlos, Spain
- Valencia, Spain
- Valladolid, Spain
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tbilisi, Georgia, Georgia; Wroclaw, Poland; Barcelona, Spain, Spain; Badalona, Spain; Madrid, Spain; Majadahonda, Spain and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.