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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05843201
• Other study ID #: AQP-009
• Status: Completed
• Phase: N/A
• Start date: February 20, 2022
• Est. completion date: December 12, 2023

Study information

• Verified date: November 2023
• Source: AquaPass Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 12, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CHF
• Chronic Heart Failure
• Edema
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa
Israel	Rabin medical center, campus Belinson	Petah tikva

Sponsors (1)

Lead Sponsor	Collaborator
AquaPass Medical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Changes in NT-ProBNP levels	Changes in NT-ProBNP levels to demonstrate the system's safety and performance	Up to 60 days
Secondary	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
Secondary	Changes in Renal function	Changes in blood electrolytes that are correlated with worsening of renal function	up to 60 days
Secondary	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