NCT05843201Completed
AquaPass Device in Treatment of CHF Patients
Evaluation of Safety, Performance, and Usability of the AquaPass Device in Treatment of CHF Patients
Source: ClinicalTrials.gov · Last updated 12 Dec 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 2 Mar 2023
- Start date
- 20 Feb 2022
- Primary completion date
- 14 Aug 2023
- Lead sponsor
- AquaPass Medical Ltd.
- Diseases
- Heart failure
- NCT number
- NCT05843201
What you commit to
- Study type: Interventional
- Participants enrolled: 18
- From 20 Feb 2022 to the primary completion date, 14 Aug 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Implanted left ventricular assist device or implant anticipated \<3 months.
Other illness
- 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.
- Subject with severe peripheral arterial disease
- History of heart transplant or actively listed for heart transplant or Left Ventricular Assist Device (LVAD).
- Malignancy or other noncardiac condition limiting life expectancy to \<12 months.
Lab values
- End-stage renal disease (eGFR\<15 ml/min/1.73 m2) or requiring dialysis.
Other
- Subject is enrolled to another clinical investigation that might interfere with this study.
- Baseline systolic blood pressure \<100 mm Hg
- Subject has any known lower body skin problems (open wounds, ulcers)
- Subject is pregnant or planning to become pregnant within the study period, or lactating mothers.
- Inability or unwillingness to comply with the study requirements.
Who the study is looking for
- Age ≥ 18
- Subject was hospitalized for worsening of chronic heart failure with fluid overload.
- Recruitment with expectation for at least 2 additional days in hospital.
- Subject has composite congestion score ≥3.
- Baseline systolic blood pressure ≥100.
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Rabin medical center, campus Belinson Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.