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Safety and Feasibility of the WhiteSwell System" (SWIFTHF)

Primary Purpose

Heart Failure, Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WhiteSwell System
Sponsored by
WhiteSwell, Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Heart Failure focused on measuring Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Advocate Health/Edwards Heart Hospital
  • Ohio State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 6, 2016
Last Updated
April 11, 2022
Sponsor
WhiteSwell, Limited
Collaborators
Avania
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1. Study Identification

Unique Protocol Identification Number
NCT02863796
Brief Title
Safety and Feasibility of the WhiteSwell System"
Acronym
SWIFTHF
Official Title
The Safety and Feasibility of the WhiteSwell System for the Reduction of Interstitial Fluid Overload in Patients With Acutely Decompensated Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
April 24, 2019 (Actual)
Study Completion Date
March 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
WhiteSwell, Limited
Collaborators
Avania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive Heart Failure
Keywords
Heart Failure

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
WhiteSwell System
Intervention Description
To promote movement of interstitial fluid to the intravascular space to allow for the body to remove it, in conjunction with a diuresis regimen.
Primary Outcome Measure Information:
Title
The Rate of adjudicated device- or procedure-related Serious Adverse Events vents
Description
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.
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Evaluation of Worsening Heart Failure During Device Therapy
Description
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)
Time Frame
During WhiteSwell Treatment Procedure (up to 72 hours)
Title
Global clinical outcome encompassing mortality, symptoms, and renal function
Description
Death through day 30;
Time Frame
Through study completion, an average of 1 month
Title
Global clinical outcome encompassing mortality, symptoms, and renal function
Description
Rehospitalization for heart failure to Day 30
Time Frame
Through study completion, an average of 1 month
Title
Global clinical outcome encompassing mortality, symptoms, and renal function
Description
Worsening renal function during device therapy (>0.5 mg/dL increase in creatinine above baseline)
Time Frame
Through study completion, an average of 1 month
Title
Global clinical outcome encompassing mortality, symptoms, and renal function
Description
Improvement in dyspnea based on the 7-point Likert scale
Time Frame
Through study completion, an average of 1 month
Title
Global clinical outcome encompassing mortality, symptoms, and renal function
Description
Change in BNP levels from baseline.
Time Frame
Through study completion, an average of 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William T. Abraham, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advocate Health/Edwards Heart Hospital
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Feasibility of the WhiteSwell System"

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