AquaPass Device in Treatment of CHF Patients

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

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

Study Overview

• Status: Completed
• Conditions: Edema; Chronic Heart Failure; CHF
• Intervention / Treatment: Device: The AquaPass System

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gali Vino; Phone Number: +972525527565; Email: gali@aquapass-medical.com
• Study Contact Backup: Name: Yaakov Nitzan; Phone Number: 972-548005493; Email: yaacov@aquapass-medical.com

Study Locations

• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Petah tikva, Israel
    • Rabin medical center, campus Belinson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18
2. Subject was hospitalized for worsening of chronic heart failure with fluid overload.
3. Recruitment with expectation for at least 2 additional days in hospital.
4. Subject has composite congestion score ≥3.
5. Baseline systolic blood pressure ≥100.

6. Subject is capable of meeting the following study requirements:

   • Subject is taking a standing diuretic dose of ≥40 mg/day
   • For patients with BMI <30 kg/m2: baseline N-terminal pro b-type natriuretic peptide (NT-proBNP)>1,600 pg/ml
   • For patients with BMI >30 kg/m2: baseline N-terminal pro b-type natriuretic peptide (NT-proBNP) >800 pg/ml
   • For patients with rate-controlled persistent or permanent Atrial Fibrillation (AF): N-terminal pro b-type natriuretic peptide (NT-proBNP) >2,400 pg/ml.

7. Subject completes 2 hours of run-in acclimatization session as follows:

   • Put on the wearable and see if the patient fits inside it comfortably.
   • Turn on console and see if the patient feels well when the skin temperatures are at least 37°C.
   • Blood Pressure, Heart Rate, Core Temperature and have not changed, relative to baseline, by more than 20%.
   • Systolic BP does not drop below 90 mmHg in 2 consecutive measurements.

Exclusion Criteria:

1. Subject is enrolled to another clinical investigation that might interfere with this study.
2. Baseline systolic blood pressure <100 mm Hg
3. Subject considered to be in the acute worsening of the heart failure: Requiring ventilation, mechanical support or is clinically unstable requiring pressors, deterioration triggered by arrythmia, infection or other medical condition unrelated to fluid overload.
4. Subject has any known lower body skin problems (open wounds, ulcers)
5. Subject with severe peripheral arterial disease
6. Subject is pregnant or planning to become pregnant within the study period, or lactating mothers.
7. End-stage renal disease (eGFR<15 ml/min/1.73 m2) or requiring dialysis.
8. Inability or unwillingness to comply with the study requirements.
9. History of heart transplant or actively listed for heart transplant or Left Ventricular Assist Device (LVAD).
10. Implanted left ventricular assist device or implant anticipated <3 months.
11. Malignancy or other noncardiac condition limiting life expectancy to <12 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients are hospitalized with chronic heart failure symptoms and fluid overloaded; Phase 1: 'In Hospital' Phase: chronic heart failure (CHF) patients are enrolled in the study when admitted to the hospital with fluid overload. Study procedures performed, alongside diuretic therapy, in the hospital. Phase 2: 'At Home' Phase: Upon investigator's decision at discharge, the patients are enrolled in the second phase of the study for additional treatment sessions at home.

Device: The AquaPass System; The system is a non-invasive, multiple use device intended for use at the hospital, at the outpatient clinic settings or at home. The system administers warm, dry air around the patients' body in order to create environmental conditions that increase the patients' sweat rate. Throughout the treatment, fluids from the interstitial compartment are removed from the body by the eccrine sweat glands.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Sweat Rate Per Hour (mL/Hr) per patient	Fluid loss from sweat will be measured after each treatment (>3 hours)	Up to 60 days
Incidences of Device and treatment-related AEs and SAEs and symptomatic changes in vital signs	Symptomatic changes in vital signs including incidences of symptomatic hypotension and a decrease of more than 50% in eGFR compared to baseline	up to 70 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	To assess the effectiveness of the AquaPass System during the treatment phase patients will be assessed for their weight prior to the first treatment and after the last treatment	Up to 60 days
Change of diuretic therapy	Documentation of changes in diuretics administration to assess safety and potential benefits with system use. (quantified by daily equivalent dose of furosemide).	Up to 60 days
Changes in NT-ProBNP levels	Changes in NT-ProBNP levels to demonstrate the system's safety and performance	Up to 60 days
Rate of Hospitalizations or emergency visits for decompensated heart failure	Documentation of CHF-related hospitalizations to assess safety and potential benefits with system use	Up to 60 days
Changes in Renal function	Changes in blood electrolytes that are correlated with worsening of renal function	up to 60 days
Change of quality of life as assessed by the KCCQ-12	Patients will be asked to complete the KCCQ-12 Questionnaire to evaluate their QoL during the study and assess the potential effect of the treatment on their well-being	Up to 60 days

Collaborators and Investigators

• Sponsor: AquaPass Medical Ltd.
• Investigators: Principal Investigator: Doron Aronson, Prof., Rambam MC

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2022
• Primary Completion (Actual): August 14, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: AQP-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No