AquaPass Device in Treatment of CHF Patients

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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

Official Title
-----------------
Evaluation of Safety, Performance, and Usability of the AquaPass Device in Treatment of CHF Patients

Conditions
-----------------
Chronic Heart Failure, Edema, CHF

Intervention / Treatment
-----------------
* Device: The AquaPass System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 Subject was hospitalized for worsening of chronic heart failure with fluid overload. Recruitment with expectation for at least 2 additional days in hospital. Subject has composite congestion score ≥3. Baseline systolic blood pressure ≥100. Subject is capable of meeting the following study requirements: Subject is taking a standing diuretic dose of ≥40 mg/day For patients with BMI <30 kg/m2: baseline N-terminal pro b-type natriuretic peptide (NT-proBNP)>1,600 pg/ml For patients with BMI >30 kg/m2: baseline N-terminal pro b-type natriuretic peptide (NT-proBNP) >800 pg/ml For patients with rate-controlled persistent or permanent Atrial Fibrillation (AF): N-terminal pro b-type natriuretic peptide (NT-proBNP) >2,400 pg/ml. Subject completes 2 hours of run-in acclimatization session as follows: Put on the wearable and see if the patient fits inside it comfortably. Turn on console and see if the patient feels well when the skin temperatures are at least 37°C. Blood Pressure, Heart Rate, Core Temperature and have not changed, relative to baseline, by more than 20%. Systolic BP does not drop below 90 mmHg in 2 consecutive measurements. Exclusion Criteria: Subject is enrolled to another clinical investigation that might interfere with this study. Baseline systolic blood pressure <100 mm Hg Subject considered to be in the acute worsening of the heart failure: Requiring ventilation, mechanical support or is clinically unstable requiring pressors, deterioration triggered by arrythmia, infection or other medical condition unrelated to fluid overload. Subject has any known lower body skin problems (open wounds, ulcers) Subject with severe peripheral arterial disease Subject is pregnant or planning to become pregnant within the study period, or lactating mothers. End-stage renal disease (eGFR<15 ml/min/1.73 m2) or requiring dialysis. Inability or unwillingness to comply with the study requirements. History of heart transplant or actively listed for heart transplant or Left Ventricular Assist Device (LVAD). Implanted left ventricular assist device or implant anticipated <3 months. Malignancy or other noncardiac condition limiting life expectancy to <12 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients are hospitalized with chronic heart failure symptoms and fluid overloaded<br>Phase 1: 'In Hospital' Phase: chronic heart failure (CHF) patients are enrolled in the study when admitted to the hospital with fluid overload. Study procedures performed, alongside diuretic therapy, in the hospital. Phase 2: 'At Home' Phase: Upon investigator's decision at discharge, the patients are enrolled in the second phase of the study for additional treatment sessions at home. | Device: The AquaPass System<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Sweat Rate Per Hour (mL/Hr) per patient | Fluid loss from sweat will be measured after each treatment (>3 hours) | Up to 60 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 | up to 70 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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). | Up to 60 days | 
| Changes in NT-ProBNP levels | Changes in NT-ProBNP levels to demonstrate the system's safety and performance | 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 | Up to 60 days | 
| Changes in Renal function | Changes in blood electrolytes that are correlated with worsening of renal function | 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 | Up to 60 days |