Evaluation of Safety, Performance, and Usability of the AquaPass Device in Treatment of CHF Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Rate of in-hospital procedures with fluid loss from sweat of >500 ml/session
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •Baseline systolic blood pressure ≥
- •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.
排除标准
- •Subject is enrolled to another clinical investigation that might interfere with this study.
- •Baseline systolic blood pressure <100 mm Hg
- •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 has any known lower body skin problems (open wounds, ulcers)
- •Subject with severe peripheral arterial disease
- •Subject is pregnant or planning to become pregnant within the study period, or lactating mothers.
- •End-stage renal disease (eGFR<15 ml/min/1.73 m2) or requiring dialysis.
- •Inability or unwillingness to comply with the study requirements.
- •History of heart transplant or actively listed for heart transplant or Left Ventricular Assist Device (LVAD).
- •Implanted left ventricular assist device or implant anticipated <3 months.
- •Malignancy or other noncardiac condition limiting life expectancy to <12 months.
结局指标
主要结局
Rate of in-hospital procedures with fluid loss from sweat of >500 ml/session
时间窗: In-Hospital Phase [2-10 days]
The primary performance endpoint for the in-hospital phase is the amount of fluid loss from sweat per treatment procedure (\~4h); the target rate of sweat production is \>500 ml/session in the in-hospital phase.
Incidences of Device and treatment-related AEs and SAEs and symptomatic changes in vital signs
时间窗: up to 70 days
Symptomatic changes in vital signs including incidences of symptomatic hypotension and a decrease of more than 50% in eGFR compared to baseline
次要结局
- Changes in Renal function(up to 60 days)
- Change in body weight(Up to 60 days)
- Change of diuretic therapy(Up to 60 days)
- Changes in NT-ProBNP levels(Up to 60 days)
- Change of quality of life as assessed by the KCCQ-12(Up to 60 days)
- Rate of Hospitalizations or emergency visits for decompensated heart failure(Up to 60 days)