Safety and Feasibility of the WhiteSwell System

Study Overview
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Brief Summary
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Early feasibility study to evaluate safety and performance of the WhiteSwell System in the treatment of fluid overload in hospitalized patients with acutely decompensated heart failure.

Detailed Description
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This study will evaluate the safety and feasibility of the WhiteSwell System for the treatment of patients hospitalized with acutely decompensated heart failure. Subjects who have been admitted to the hospital less than 72 hours for ADHF will be evaluated for inclusion into the study.

Official Title
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The Safety and Feasibility of the WhiteSwell System for the Reduction of Interstitial Fluid Overload in Patients With Acutely Decompensated Heart Failure

Conditions
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Heart Failure, Congestive Heart Failure

Intervention / Treatment
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* Device: WhiteSwell System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 Subject is admitted to the hospital with a primary diagnosis of acute decompensated heart failure (ADHF). Subjects receiving IV diuretic for ADHF and demonstrating fluid overload. This includes a minimum of 2 of the following: peripheral edema ≥ +2 (on a 0 to +3 scale, indicating indentation of skin with mild digital pressure that requires 10 s or more to resolve in any dependent area including extremities or sacral region); jugular venous distension ≥8 cm H2O pulmonary edema or pleural effusion on chest radiograph enlarged liver or ascites; paroxysmal nocturnal dyspnea or ≥ two-pillow orthopnea; dyspnea at rest with respiration rate ≥20 per minute Renal function parameters: 30<eGFR<80 Biomarkers: BNP/pro-BNP BNP>400 pg/ml or NT-pro-BNP>1,600 pg/ml For patients with rate-controlled persistent or permanent AF: BNP>600 pg/ml or NT-pro-BNP>2,400 pg/ml Subject must be able to be enrolled into the trial ≤ 72 hours of their admission to the hospital Subject agrees to comply with all follow-up evaluations Subject has provided written informed consent; or if unable to perform informed consent, written informed consent on behalf of the subject has been provided by a legally-authorized representative Exclusion Criteria: Subjects requiring inotropic therapy, mechanical ventilation, or mechanical circulatory support Subjects developing worsening renal function (creatinine >0.5 mg/dL above baseline) within the time frame from admission to enrollment. Subject has experienced a thromboembolic event (eg, pulmonary embolism (PE), deep vein thrombosis (DVT)) within the previous 6 months Subject has contraindications to systemic anticoagulation Subject with INR >1.8 or on novel anticoagulants (NOACs). Subjects who have taken NOACs may be enrolled if a minimum of 48 hours has passed since their last dose, with the exception of subjects on Dabigatran, who may not be enrolled. Subject has mechanical heart valve. Subject with systolic blood pressure < 90mmHg at time of enrollment Subject has evidence of active infection Subject has anatomical abnormalities and variations, or visualization of the insertion and deployment site does not enable safe venous access and device deployment as assessed by ultrasound Subject vein diameters proximal and distal to the internal jugular/subclavian vein bifurcation in area of device placement less than 13.5mm and/or greater than 205mm. Subject has experienced transient ischemic attack (TIA) events or cerebrovascular events (CVA) at previous 6 months Subject with Acute coronary syndrome (ACS). Subject with severe concomitant disease expected to prolong hospitalization or expected to cause death in ≤ 90 days Subject is pregnant. Pregnancy confirmed by positive urine or serum test, or lactating mothers

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>This prospective, multi-center, single arm study is designed to evaluate the safety and feasibility of the WhiteSwell System in the reduction of interstitial fluid overload in patients with acutely decompensated heart failure (ADHF) | Device: WhiteSwell System<br>* To promote movement of interstitial fluid to the intravascular space to allow for the body to remove it, in conjunction with a diuresis regimen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Rate of adjudicated device- or procedure-related Serious Adverse Events vents | The rate of adjudicated device- or procedure-related Serious Adverse Events (SAEs). All primary safety endpoints will be reported as-adjudicated by the designated Clinical Events Committee (CEC) during treatment and through the 30-day follow-up period. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure