Safety and Feasibility of the WhiteSwell System"

NCT02863796 | Completed FDA Device

• 1 other identifier: 2016-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Heart Failure; Congestive Heart Failure

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (6)

• Evaluation of Worsening Heart Failure During Device Therapy

  During WhiteSwell Treatment Procedure (up to 72 hours)

• Global clinical outcome encompassing mortality, symptoms, and renal function

  Through study completion, an average of 1 month

• Global clinical outcome encompassing mortality, symptoms, and renal function

  Through study completion, an average of 1 month

Study Arms (1)

Single arm

EXPERIMENTAL

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

Interventions

WhiteSwell System DEVICE

To promote movement of interstitial fluid to the intravascular space to allow for the body to remove it, in conjunction with a diuresis regimen.

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• WhiteSwell, Limited: lead
• Avania: collaborator

Study Sites (2)

Advocate Health/Edwards Heart Hospital

Naperville, Illinois, 60540, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• William T. Abraham, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: August 11, 2016
• Study Start: August 1, 2016
• Primary Completion: April 24, 2019
• Study Completion: March 14, 2022
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)