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RECRUITING
NCT06360380
NA

Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System

Sponsor: AquaPass Medical Ltd.

View on ClinicalTrials.gov

Summary

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 select if to be treated at their home or in the outpatient clinic.

Official title: REFORM-HF™ Reducing Fluid Overload Using Renal Independent SysteM in Heart Failure Patients

Key Details

Gender

All

Age Range

21 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-09-05

Completion Date

2025-01-29

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

DEVICE

AquaPass System

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

Locations (4)

Rochester Regional Health

Rochester, New York, United States

Cone Health Advanced Heart Failure Clinic at Moses Cone

Greensboro, North Carolina, United States

Rambam Medical Campus

Haifa, Israel

Rabin Medical Center

Petah Tikva, Israel