AquaPass Device in Treatment of CHF Patients

NCT ID: NCT05843201

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-20
• Study Completion Date: 2023-12-12

Brief 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

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

Conditions

Chronic Heart Failure; Edema; CHF

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

The AquaPass System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AquaPass Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Doron Aronson, Prof.

Role: PRINCIPAL_INVESTIGATOR

Rambam MC

Locations

Rambam Health Care Campus

Haifa, , Israel

Rabin medical center, campus Belinson

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

AQP-009

Identifier Type: -

Identifier Source: org_study_id