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

Part of paid clinical trials in Rochester, New York.

Sponsor
AquaPass Medical Ltd.
Study ID
NCT06360380
Status
Recruiting
Apply to this trial

Conditions

  • CKD Stage 3
  • Chronic Heart Failure

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Sep 5, 2024
Status verified
Sep 2024
Primary completion
Jan 3, 2025
Completion
Jan 29, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: AquaPass
    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
  • No Intervention: Control
    An observation visit, during which data will be collected on fluid intake, fluid output, congestion score, body weight, and quality of life. These data will serve as a control for the efficacy primary endpoint comparison.

Primary Outcome Measure

AquaPass Performance Evaluation [ Time Frame: 5 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Rochester Regional HealthRochesterNew York14621
Scott C Feitell, DO
[email protected]
(585) 442 5320
Cone Health Advanced Heart Failure Clinic at Moses ConeGreensboroNorth Carolina27401
Aditya Sabharwal, DO
[email protected]

Find similar trials in Rochester, NY

By research site
Rochester Regional Health· Rochester, NYCone Health Advanced Heart Failure Clinic at Moses Cone· Greensboro, NC

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