NCT06401109

Naturally Controlled Decongestion Using Renal Independent System in ADHF Patients, a European Registry

Evaluating the Safety and Efficacy of the AquaPass System a Renal-independent Fluid Removal System in ADHF Patients Suffering From Fluid Overload. a European Registry

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: AquaPass Medical Ltd. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The AquaPass is a non-invasive, renal-intended system designed to enhance fluid transfer through the skin, by increasing sweat rate, to treat fluid overload in heart failure patients. This study will further evaluate the safety, efficacy, and usability of the AquaPass system in the hospital and home settings.

Detailed description

The AquaPass system is non-invasive and functions independently of the renal system, targeting the direct removal of fluids directly from the interstitial compartment through the skin, by activating the eccrine sweat glands. The patient wears a component that is connected to a control unit, which induces warm air to create a controlled environment around the skin, stimulating sweat production. The sweat evaporates instantly, ensuring that the patient remains dry and comfortable. In this study, the investigators would like to further investigate the efficacy of the system, when used in hospital settings in patients hospitalized for decompensated heart failure and fluid overload, and to continue the treatment in their homes, immediately after the hospitalization, for another 30 days.

Conditions

• Chronic Heart Failure
• Fluid Overload
• Acute Decompensated Heart Failure
• Edema

Interventions

Type	Name	Description
DEVICE	AquaPass	The AquaPass system works by activating the body's natural sweating mechanism to remove excess fluid from the interstitial compartment. This process is achieved by wearing a garment that creates optimal microclimate conditions around the skin. The system is controlled by a portable unit that delivers warm air to the wearable component while ensuring patient safety.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-02-01
• Completion: 2026-05-01
• First posted: 2024-05-06
• Last updated: 2024-05-06