Safety and Feasibility of the WhiteSwell System"

NCT ID: NCT02863796

Last Updated: 2022-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-01
• Study Completion Date: 2022-03-14

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.

Conditions

Heart Failure; Congestive Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

WhiteSwell System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avania

INDUSTRY

Sponsor Role: collaborator

WhiteSwell, Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William T. Abraham, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Advocate Health/Edwards Heart Hospital

Naperville, Illinois, United States

Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2016-001

Identifier Type: -

Identifier Source: org_study_id