The AquaPass System is intended for enhancing fluid transfer through the skin, by increased sweat rate, in fluid overloaded patients. This study will examine safety, performance and usability of the AquaPass device in two phases: Phase 1: Hospitalization treatment. Phase 2: Home/outpatient clinic treatment
The AquaPass System is intended for enhancing fluid transfer through the skin, by increased sweat rate, in fluid overloaded patients. This study will examine safety, performance and usability of the AquaPass device in two phases: Phase 1: Hospitalization treatment: This phase will begin when the patients are hospitalized with chronic heart failure symptoms and fluid overloaded and undergo sequential treatments. This phase will be conducted using a prospective case-control design, with measuring endpoint during hospitalization and follow-up (after discharge). Phase 2: Home treatment: Upon investigator decision at discharge, patients will use Aqua-Pass device at home or at outpatient, after discharge, aiming to refine fluid management and prevent re-admission. This phase will require a separate Informed Consent Form (ICF) and will be conducted using a prospective single-group pre-post design. * A multi-center, prospective, open label, one arm study. * Chronic heart failure patients will be enrolled into the study when admitted to the hospital with fluid overload. * During the in-hospitalization treatment phase, patients will undergo up to 5 procedures with the Aqua-Pass device between 3-8 hours. * Following discharge and upon investigator decision, patients will sign a dedicated ICF and continue the Aqua-Pass treatments at home or in the outpatient clinic for up to 60 days, at a rate of 1-4 treatments per week. * Follow up assessments, either during visit or over the phone, 7±2 days from the last procedure
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
The system is a non-invasive, multiple use device intended for use at the hospital, at the outpatient clinic settings or at home. The system administers warm, dry air around the patients' body in order to create environmental conditions that increase the patients' sweat rate. Throughout the treatment, fluids from the interstitial compartment are removed from the body by the eccrine sweat glands.
Rambam Health Care Campus
Haifa, Israel
Rabin medical center, campus Belinson
Petah Tikva, Israel
Rate of in-hospital procedures with fluid loss from sweat of >500 ml/session
The primary performance endpoint for the in-hospital phase is the amount of fluid loss from sweat per treatment procedure (\~4h); the target rate of sweat production is \>500 ml/session in the in-hospital phase.
Time frame: In-Hospital Phase [2-10 days]
Incidences of Device and treatment-related AEs and SAEs and symptomatic changes in vital signs
Symptomatic changes in vital signs including incidences of symptomatic hypotension and a decrease of more than 50% in eGFR compared to baseline
Time frame: up to 70 days
Change in body weight
To assess the effectiveness of the AquaPass System during the treatment phase patients will be assessed for their weight prior to the first treatment and after the last treatment
Time frame: Up to 60 days
Change of diuretic therapy
Documentation of changes in diuretics administration to assess safety and potential benefits with system use. (quantified by daily equivalent dose of furosemide).
Time frame: Up to 60 days
Changes in NT-ProBNP levels
Changes in NT-ProBNP levels to demonstrate the system's safety and performance
Time frame: Up to 60 days
Rate of Hospitalizations or emergency visits for decompensated heart failure
Documentation of CHF-related hospitalizations to assess safety and potential benefits with system use
Time frame: Up to 60 days
Changes in Renal function
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Changes in blood electrolytes that are correlated with worsening of renal function
Time frame: up to 60 days
Change of quality of life as assessed by the KCCQ-12
Patients will be asked to complete the KCCQ-12 Questionnaire to evaluate their QoL during the study and assess the potential effect of the treatment on their well-being
Time frame: Up to 60 days