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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 be treated in the hospital 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 - 79 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-08-12

Completion Date

2027-04

Last Updated

2026-07-06

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 (10)

UC San Diego Health-Sulpizio Cardiovascular Center

La Jolla, California, United States

UC San Francisco

San Francisco, California, United States

University of Minnesota

Minneapolis, Minnesota, United States

Northwell Health- Lenox Hill Hospital

New York, New York, United States

Rochester Regional Health

Rochester, New York, United States

Mission Hospital

Asheville, North Carolina, United States

Cone Health Advanced Heart Failure Clinic at Moses Cone

Greensboro, North Carolina, United States

Austin Heart Hospital

Austin, Texas, United States

Rambam Medical Campus

Haifa, Israel

Rabin Medical Center

Petah Tikva, Israel