Volume Optimization Incorporating Negative Pressure Diuresis in Heart Failure (VOID-HF)
Volume Optimization Incorporating Negative Pressure Diuresis in Heart Failure (VOID-HF)
The Cardiorenal Syndrome during Acute decompensated heart failure (ADHF) with persistent
 congestion despite high dose IV diuretic therapy is associated with remarkable morbidity,
 which can include the need for renal dialysis or ultrafiltration, an increased length of
 stay, and high mortality rates. The aims and purpose of this feasibility clinical research
 trial are: 1. to evaluate the safety profiles associated with performing negative pressure
 diuresis for the treatment of hypervolemia associated with the cardiorenal syndrome during
 ADHF with persistent congestion despite high dose IV diuretic therapy via the investigational
 JuxtaFlow® System, and 2. to evaluate the effectiveness of the investigational JuxtaFlow
 System in treatment of hypervolemia associated with ADHF.
Inclusion Criteria:

 1. Male or female patients ≥22 years of age

 2. Patients admitted with primary diagnosis of ADHF

 3. Persistent volume overload with venous congestion despite at least 24 hours of IV
 diuretic therapy, including either a single bolus ≥ 100 mg or continuous drip ≥ 10
 mg/hour of furosemide equivalent, where:

 1. Volume overload defined by the presence of pulmonary edema, 2+ peripheral edema,
 or orthopnea

 2. Venous congestion defined by at least one of the following:

 i. Jugular venous pressure > 10 cm on physical exam ii. Central venous pressure > 10
 mmHg iii. Pulmonary capillary wedge pressure > 22 mmHg c) Evidence of low natriuretic
 response to high dose diuretic therapy defined by spot urine sodium < 70 mmol

 4. Ability to have the JuxtaFlow® System catheters placed at bedside

 5. Anticipated to have an inpatient hospital admission that is ≥ 72 hours

 6. Patients that are willing and able to provide informed consent for this research
 trial, or if the patient is not able to provide consent due to their clinical
 condition, a legal guardian, spouse, or next of kin to the patient with medical power
 of attorney that is willing to provide consent for the patient's participation in this
 research trial

 7. Patients who agree to comply with the study procedures and specified evaluations

 Exclusion Criteria:

 1. Females who are pregnant or nursing mothers

 2. Creatinine > 3.0 mg/dL at admission to the hospital

 3. Systolic blood pressure < 100 mmHg at the time of enrollment

 4. Clinical instability likely to require the addition of intravenous vasoactive drugs,
 vasodilators and/or inotropic agents.

 5. Alternative explanation for the renal impairment causing the persistent volume
 overload, such as obstructive nephropathy, contrast induced nephropathy, or acute
 tubular necrosis

 6. Any patient with an eGFR < 15 ml/min or prior diagnosis of CKD 5

 7. Any patient presenting with hematuria as defined by urine dipstick reading of > 1+
 blood

 8. Any patient presenting with proteinuria as defined by urine dipstick reading of > 3+
 protein.

 9. Any patient that would not potentially benefit from this therapy in the opinion of the
 investigator

 10. Any patient with a current upper or lower urinary tract infection (tested during
 pre-screening)

 11. Any patient with a malignancy of the upper urinary tract

 12. Any patient who are currently experiencing unexplained/unexpected proteinuria as
 determined by the investigator

 13. Any patient with a current unrepaired ureteral avulsion as determined by the
 investigator

 14. Any patient that would require an MRI between enrollment and completion of the
 post-treatment baseline period

 15. Any secondary condition as determined by the investigator that would place the subject
 at an increased risk, or preclude the subject's full compliance with the study
 procedures, including injuries to the urinary organs and/or external genitals

 16. Any use of an iodinated radiocontrast material in the past 72 hours prior to study
 enrollment or anticipated use of intravenous contrast during the current
 hospitalization.

 17. Pre-enrollment ultrasound revealing any of the following:

 1. Congenital abnormality in either kidney

 2. Only one kidney

 3. Presence of debris, stones or an obstruction in the renal pelvis, ureter or
 urinary tract

 18. Current or planned treatment with an investigational drug (IND), device (IDE), or
 other investigational intervention within 3 months prior to or during participation in
 this clinical trial