The AquaPass is a non-invasive, renal-intended system designed to enhance fluid transfer through the skin, by increasing sweat rate, to treat fluid overload in heart failure patients. This study will further evaluate the safety, efficacy, and usability of the AquaPass system in the hospital and home settings.
The AquaPass system is non-invasive and functions independently of the renal system, targeting the direct removal of fluids directly from the interstitial compartment through the skin, by activating the eccrine sweat glands. The patient wears a component that is connected to a control unit, which induces warm air to create a controlled environment around the skin, stimulating sweat production. The sweat evaporates instantly, ensuring that the patient remains dry and comfortable. In this study, the investigators would like to further investigate the efficacy of the system, when used in hospital settings in patients hospitalized for decompensated heart failure and fluid overload, and to continue the treatment in their homes, immediately after the hospitalization, for another 30 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The AquaPass system works by activating the body's natural sweating mechanism to remove excess fluid from the interstitial compartment. This process is achieved by wearing a garment that creates optimal microclimate conditions around the skin. The system is controlled by a portable unit that delivers warm air to the wearable component while ensuring patient safety.
Average Sweat Rate Per Hour per patient
An average sweat rate of 150 ml/hr per patient at hospital and at home
Time frame: 30 days
Incidence of device- and procedure-related side-effects
Incidences of system and treatment-related AEs and SAEs including symptomatic changes in vital signs
Time frame: 30 days
Incidence of worsening renal function
Incidence of worsening renal function, measured as an increase of Creatinine levels by \>0.5mg/dL
Time frame: 30 days
Fluid Overload Related Hospitalizations
Hospitalization or ED visit for decompensated heart failure
Time frame: 30 days
Changes in congestion score
to evaluate the effect of the AquaPass treatment on congestion score
Time frame: 30 days
Changes in Diuretics Dose
Documentation of changes in diuretics administration to assess safety and potential benefits with system use.
Time frame: 30 days
Change of quality of life
Assessment of the quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The minimal score is zero '0' and the highest is '100' when higher scores represent a better outcome for the patient.
Time frame: 30 days
Changes in NT-ProBNP levels
Changes in NT-ProBNP levels to demonstrate the system's safety and clinical performance
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Time frame: 30 days
Change in body weight
To evaluate the effectiveness of the AquaPass System. During the study patients will weighed before and after each treatment. The weight before the first treatment and the weight after the last treatment will be used to assess the treatment performance
Time frame: 30 days