AquaPass Device in Treatment of CHF Patients

Chronic Heart Failure Clinical Trial

Official title: Evaluation of Safety, Performance, and Usability of the AquaPass Device in Treatment of CHF Patients

Status Completed

Clinical Trial Summary

The AquaPass System is intended for enhancing fluid transfer through the skin, by increased sweat rate, in fluid overloaded patients.

This study will examine safety, performance and usability of the AquaPass device in two phases:

Phase 1: Hospitalization treatment. Phase 2: Home/outpatient clinic treatment

Clinical Trial Description

The AquaPass System is intended for enhancing fluid transfer through the skin, by increased sweat rate, in fluid overloaded patients.

This study will examine safety, performance and usability of the AquaPass device in two phases:

Phase 1: Hospitalization treatment: This phase will begin when the patients are hospitalized with chronic heart failure symptoms and fluid overloaded and undergo sequential treatments. This phase will be conducted using a prospective case-control design, with measuring endpoint during hospitalization and follow-up (after discharge).

Phase 2: Home treatment: Upon investigator decision at discharge, patients will use Aqua-Pass device at home or at outpatient, after discharge, aiming to refine fluid management and prevent re-admission. This phase will require a separate Informed Consent Form (ICF) and will be conducted using a prospective single-group pre-post design.

• A multi-center, prospective, open label, one arm study.

• Chronic heart failure patients will be enrolled into the study when admitted to the hospital with fluid overload.

• During the in-hospitalization treatment phase, patients will undergo up to 5 procedures with the Aqua-Pass device between 3-8 hours.

• Following discharge and upon investigator decision, patients will sign a dedicated ICF and continue the Aqua-Pass treatments at home or in the outpatient clinic for up to 60 days, at a rate of 1-4 treatments per week.

• Follow up assessments, either during visit or over the phone, 7±2 days from the last procedure ;

Related Conditions & MeSH terms

• CHF
• Chronic Heart Failure
• Edema
• Heart Failure

• NCT number: NCT05843201
• Study type: Interventional
• Source: AquaPass Medical Ltd.
• Status: Completed
• Phase: N/A
• Start date: February 20, 2022
• Completion date: December 12, 2023