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The REFORM-HF study aims to test a new technology, AQUAPASS, designed to assist patients experiencing symptoms of fluid overload due to Heart Failure.
Patients will wear a lightweight suit that helps remove excess fluids through their sweat.
The investigators want to see if the AQUAPASS system can remove an additional 500mL of fluids during treatment, alongside patients' regular medications like diuretics.
Participants will be treated in the hospital or in the outpatient clinic.
This study is being conducted to demonstrate the safety and effectiveness of the AquaPass System in reducing fluid overload in patients with decompensated heart failure and chronic kidney disease stage 2-3 who are not responding adequately or resistant to current medical treatment.
The study checks if patients' fluid loss as a result of taking diuretics medications is improved when using AQUAPASS in parallel to this treatment.
The evaluation of success is done by comparing participants' weight before and after the use of the AQUAPASS system, to evaluate if the system effectively removes excess fluids.
Patients will also have blood and urine tests every morning to check how well their kidneys and heart are functioning.
The first visit will be observation only, without using AQUAPASS. This will serve as the baseline data. The investigators will compare the data of the AQUAPASS treatments with this baseline to measure the effectiveness of the system in removing excess fluids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AquaPass | Experimental | An AquaPass treatment session (up to 5-Hrs.) will be administered and supervised by certified study staff |
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| Control | No Intervention | An observation visit, during which data will be collected on fluid intake, fluid output, congestion score, and body weight. These data will serve as a control for the efficacy primary endpoint comparison. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AquaPass System | Device | a treatment session of up to 5 hours with the AquaPass system, evaluating net fluid removal for efficacy analysis and effect on vital signs for safety analysis |
| Measure | Description | Time Frame |
|---|---|---|
| AQUAPASS Performance Evaluation | Average Net Fluid Loss calculated as the difference in weight between pre- and post-AQUAPASS treatment sessions, in comparison to the Control Day observation. Total Average Net Fluid Loss during the Treatment Phase should be ≥ 500gr. as compared to the Total Average Net Fluid Loss during the Control Phase. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| AQUAPASS Safety Evaluation | Incidence of device- and procedure-related side effects - defined as ANY of the following events during or immediately after device use:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Scott C Feitell, DO | Contact | (585) 442 5320 | scott.feitell@rochesterregional.org | |
| Julie Mooney, RN | Contact | 585-738-3409 | julie.mooney@rochesterregional.org |
| Name | Affiliation | Role |
|---|---|---|
| Scott C Feitell, DO | Rochester Regional Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Health-Sulpizio Cardiovascular Center | Recruiting | La Jolla | California | 92037 | United States |
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A prospective, multicenter, single-arm, within-subject-controlled, pivotal trial, enrolling subjects with decompensated heart failure inadequately responding to current medical treatment, indicated by persistent or worsening congestion despite a daily dose of ≥80 mg furosemide or equivalent loop diuretics.
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| 6 hours |
| UC San Francisco | Recruiting | San Francisco | California | 94143 | United States |
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| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| Northwell Health- Lenox Hill Hospital | Recruiting | New York | New York | 10075 | United States |
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| Rochester Regional Health | Recruiting | Rochester | New York | 14621 | United States |
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| Mission Hospital | Recruiting | Asheville | North Carolina | 28801 | United States |
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| Cone Health Advanced Heart Failure Clinic at Moses Cone | Recruiting | Greensboro | North Carolina | 27401 | United States |
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| Austin Heart Hospital | Recruiting | Austin | Texas | 78705 | United States |
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| Rambam Medical Campus | Recruiting | Haifa | 3109601 | Israel |
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| Rabin Medical Center | Recruiting | Petah Tikva | 49100 | Israel |
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