Recruiting

REFORM-HFAquaPass System for Fluid Overload Reduction in Heart Failure Patients with Chronic Kidney Disease

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to evaluate the performance of the AquaPass System in reducing fluid overload in heart failure patients with chronic kidney disease, by comparing the average net fluid loss during treatment sessions with that of a control phase.

What is being tested

AquaPass System

Device
Who is being recruted

From 21 to 80 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2024
See protocol details

Summary

Principal SponsorAquaPass Medical Ltd.
Study ContactScott C Feitell, DO
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 5, 2024

Actual date on which the first participant was enrolled.

This clinical study aims to test a new system, called the AquaPass System, designed to help people with heart failure and moderate kidney disease who are not improving with their usual medications. These patients often suffer from fluid buildup, which is hard to manage with current treatments. The study focuses on those with decompensated heart failure and chronic kidney disease at stages 2-3, a group that struggles with fluid overload. The goal is to determine if this system can effectively reduce excess fluid in such patients, which can potentially lead to better management of their condition and improve their quality of life. Participants in the study will use the AquaPass System alongside their regular diuretic medications. The effectiveness of the system is measured by checking any weight loss, which indicates fluid loss, before and after using AquaPass. Additionally, blood and urine tests are conducted each morning to monitor kidney and heart function. Initially, patients will be observed without using the AquaPass to gather baseline data, which will then be compared with results from subsequent AquaPass treatments to determine its effectiveness in eliminating extra fluids from the body.

Official TitleREFORM-HF™ Reducing Fluid Overload Using Renal Independent SysteM in Heart Failure Patients
NCT06360380
Principal SponsorAquaPass Medical Ltd.
Study ContactScott C Feitell, DO
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

8 inclusion criteria required to participate
Age ≥21 years and < 80 years
Patient, with known decompensated heart failure and/or CKD stage 2 or more presenting with fluid overload, defined by a congestion score of ≥3, who are not responding adequately or are resistant to current medical treatment as evidenced by persistent or worsening congestion, despite a daily dose of 40 mg furosemide or greater or the equivalent dose of another loop diuretic.
Patients with no Heart Failure related hospitalization in the past 30 days
No change in diuretic regimen in the past 7 days
Show More Criteria
17 exclusion criteria prevent from participating
Patients with active infections
Patient considered to be in the acute worsening of heart failure: Requiring ventilation, mechanical support or is clinically unstable requiring pressors, deterioration triggered by arrhythmia, infection, or other medical condition unrelated to fluid overload.
Patient has any known or visible lower body (non-facial) skin problems (open wounds, ulcers, infections)
Patient with severe peripheral arterial disease
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
An AquaPass treatment session (up to 5-Hrs.) will be administered in the outpatient settings or at home and supervised by a certified study staff

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Recruiting

Rochester Regional Health

Rochester, United StatesOpen Rochester Regional Health in Google Maps
Recruiting

Cone Health Advanced Heart Failure Clinic at Moses Cone

Greensboro, United States
Recruiting

Rambam Medical Campus

Haifa, Israel
Recruiting

Rabin Medical Center

Petah Tikva, Israel
Recruiting
4 Study Centers