Chronic Heart Failure
Conditions
Keywords
CHF, Edema
Brief summary
The purpose of this study is to demonstrate safety and performance of AquaPass System for enhancing fluid transfer through the skin, by increased sweat rate, in edematous patients.
Detailed description
This is a prospective, single-center, open label single arm study, conducted in two phases: up to 6 healthy subjects (Phase 1) and up to 16 chronic heart failure (CHF) patients (Phase 2). After being informed about the study, requirements and potential risks, consenting patients will be enrolled and undergo 3 procedures (each procedure up to 3 (±1) hours operation), with 4-10 days between each procedure. All patients will be followed up for 7 (±2) days from final procedure.
Interventions
DEVICEThe AquaPass System
The AquaPass device is a capsule that creates relatively homogenous temperature around the patients' lower body, while controlling and maintaining at a low percentage the relative humidity within the capsule thus enabling controlled environment that enhances sweat rate.
Sponsors
AquaPass Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Phase 1: Healthy subjects: 1. Age ≥ 18 2. Subject has been informed on the nature of the study and has provided informed consent 3. Subject is capable of meeting study requirements Phase 2: CHF Patients: 1. Age ≥ 18 and diagnosed with CHF 2. Subject has 2 or more score for pitting edema 3. Subject is taking diuretic medications at home 4. Subject has been informed on the nature of the study and has provided informed consent 5. Subject is capable of meeting study requirements
Exclusion criteria
Phase 1: Healthy subjects: 1. Subject is enrolled to another clinical investigation that might interfere with this study 2. Subject is pregnant or planning to become pregnant within the study period, or lactating mothers 3. Subject has no known sensitivity to Neoprene Phase 2: CHF Patients: 1. Subject is enrolled to another clinical investigation that might interfere with this study 2. Subject is admitted to the hospital for acute decompensated or acute heart failure 3. Subject has any known lower body skin problems (open wounds, ulcers) 4. eGFR\<15 ml/min/m2 5. Subject with severe peripheral arterial disease 6. Subject is pregnant or planning to become pregnant within the study period, or lactating mothers 7. Subject has known sensitivity to Neoprene
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Events | 30 days | Device related SAE |
| System Activation | During procedure | Ability to activate the AquaPass System and control skin temperature to levels between 33°C and 38°C |
| Treatment Toleration | During procedure | Subjects can tolerate at least 2 hours of treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Urinary sodium concentration | Before and and immediately after procedure | Change in urinary sodium concentration |
| Dyspnea | Before and and immediately after procedure | Change in dyspnea score |
| Pitting edema | Before and and immediately after procedure | Change in pitting edema score |
| CBC | Before and and immediately after procedure | Change in Complete Blood Count |
| JVD | Before and and immediately after procedure | Change in jugular venous distention (JVD) score |
| Weight | During and and immediately after procedure | Changes in weight |
| Skin Changes | Before and and immediately after procedure | Signs of burns grade 1 or more |
| NT-proBNP (phase 2 only) | Before and and immediately after procedure | Change in N-terminal prohormone of brain natriuretic peptide levels |
| Serum creatinine, BUN and Sodium | Before and and immediately after procedure | Change in serum creatinine, blood urea nitrogen (BUN) and sodium levels |
Countries
Israel
Outcome results
None listed