Safety and Feasibility of the WhiteSwell System" (SWIFTHF)

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Congestive Heart Failure
• Intervention / Treatment: Device: WhiteSwell System

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Naperville, Illinois, United States, 60540
      • Advocate Health/Edwards Heart Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age >18
2. Subject is admitted to the hospital with a primary diagnosis of acute decompensated heart failure (ADHF).

3. 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
4. Renal function parameters: 30<eGFR<80

5. Biomarkers: BNP/pro-BNP

   1. BNP>400 pg/ml or NT-pro-BNP>1,600 pg/ml
   2. For patients with rate-controlled persistent or permanent AF: BNP>600 pg/ml or NT-pro-BNP>2,400 pg/ml
6. Subject must be able to be enrolled into the trial ≤ 72 hours of their admission to the hospital
7. Subject agrees to comply with all follow-up evaluations
8. 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:

1. Subjects requiring inotropic therapy, mechanical ventilation, or mechanical circulatory support
2. Subjects developing worsening renal function (creatinine >0.5 mg/dL above baseline) within the time frame from admission to enrollment.
3. Subject has experienced a thromboembolic event (eg, pulmonary embolism (PE), deep vein thrombosis (DVT)) within the previous 6 months
4. Subject has contraindications to systemic anticoagulation
5. 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.
6. Subject has mechanical heart valve.
7. Subject with systolic blood pressure < 90mmHg at time of enrollment
8. Subject has evidence of active infection
9. 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
10. 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.
11. Subject has experienced transient ischemic attack (TIA) events or cerebrovascular events (CVA) at previous 6 months
12. Subject with Acute coronary syndrome (ACS).
13. Subject with severe concomitant disease expected to prolong hospitalization or expected to cause death in ≤ 90 days
14. Subject is pregnant. Pregnancy confirmed by positive urine or serum test, or lactating mothers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm; 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; To promote movement of interstitial fluid to the intravascular space to allow for the body to remove it, in conjunction with a diuresis regimen.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Worsening Heart Failure During Device Therapy	Worsening heart failure during device therapy, defined as worsening signs and/or symptoms of HF requiring intensification of HF therapy, including need for intensification of intravenous therapy with inotropes or mechanical therapy (e.g., mechanical ventilation, circulatory support)	During WhiteSwell Treatment Procedure (up to 72 hours)
Global clinical outcome encompassing mortality, symptoms, and renal function	Death through day 30;	Through study completion, an average of 1 month
Global clinical outcome encompassing mortality, symptoms, and renal function	Rehospitalization for heart failure to Day 30	Through study completion, an average of 1 month
Global clinical outcome encompassing mortality, symptoms, and renal function	Worsening renal function during device therapy (>0.5 mg/dL increase in creatinine above baseline)	Through study completion, an average of 1 month
Global clinical outcome encompassing mortality, symptoms, and renal function	Improvement in dyspnea based on the 7-point Likert scale	Through study completion, an average of 1 month
Global clinical outcome encompassing mortality, symptoms, and renal function	Change in BNP levels from baseline.	Through study completion, an average of 1 month

Collaborators and Investigators

• Sponsor: WhiteSwell, Limited
• Collaborators: Avania
• Investigators: Principal Investigator: William T. Abraham, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): April 24, 2019
• Study Completion (Actual): March 14, 2022

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 11, 2016

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Heart Failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2016-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes