๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-02

Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System (NCT06360380)

REFORM-HFโ„ข Reducing Fluid Overload Using Renal Independent systeM in Heart Failure Patients

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: AquaPass Medical Ltd.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: UC San Diego Health-Sulpizio Cardiovascular Center โ€” La Jolla, California

Age range: 21 Years to 79 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (10 Sites)

  • UC San Diego Health-Sulpizio Cardiovascular Center โ€” La Jolla, California
  • UC San Francisco โ€” San Francisco, California
  • University of Minnesota โ€” Minneapolis, Minnesota
  • Northwell Health- Lenox Hill Hospital โ€” New York, New York
  • Rochester Regional Health โ€” Rochester, New York
  • Mission Hospital โ€” Asheville, North Carolina
  • Cone Health Advanced Heart Failure Clinic at Moses Cone โ€” Greensboro, North Carolina
  • Austin Heart Hospital โ€” Austin, Texas
  • Rambam Medical Campus โ€” Haifa,
  • Rabin Medical Center โ€” Petah Tikva,

๐Ÿ“ž Contact the Study Coordinator

Phone: (585) 442-5320

Email: scott.feitell@rochesterregional.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—