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

NCT06360380 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • AquaPass Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Scott C Feitell, DO · Rochester Regional Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-05
Primary Completion
2025-01-03
Completion
2025-01-29
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06360380 on ClinicalTrials.gov