Safety and Feasibility of the WhiteSwell System"

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02863796
• Other study ID #: 2016-001
• Status: Completed
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: March 14, 2022

Study information

• Verified date: April 2022
• Source: WhiteSwell, Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 14, 2022
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio
United States	Advocate Health/Edwards Heart Hospital	Naperville	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
WhiteSwell, Limited	Avania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Global clinical outcome encompassing mortality, symptoms, and renal function	Death through day 30;	Through study completion, an average of 1 month
Other	Global clinical outcome encompassing mortality, symptoms, and renal function	Rehospitalization for heart failure to Day 30	Through study completion, an average of 1 month
Other	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
Other	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
Other	Global clinical outcome encompassing mortality, symptoms, and renal function	Change in BNP levels from baseline.	Through study completion, an average of 1 month
Primary	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