Evaluating the Safety and Efficacy of the AquaPass System a Renal-independent Fluid Removal System in ADHF Patients Suffering From Fluid Overload. a European Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Average Sweat Rate Per Hour per patient
研究概览
简要总结
The AquaPass is a non-invasive, renal-intended system designed to enhance fluid transfer through the skin, by increasing sweat rate, to treat fluid overload in heart failure patients.
This study will further evaluate the safety, efficacy, and usability of the AquaPass system in the hospital and home settings.
详细描述
The AquaPass system is non-invasive and functions independently of the renal system, targeting the direct removal of fluids directly from the interstitial compartment through the skin, by activating the eccrine sweat glands.
The patient wears a component that is connected to a control unit, which induces warm air to create a controlled environment around the skin, stimulating sweat production. The sweat evaporates instantly, ensuring that the patient remains dry and comfortable.
In this study, the investigators would like to further investigate the efficacy of the system, when used in hospital settings in patients hospitalized for decompensated heart failure and fluid overload, and to continue the treatment in their homes, immediately after the hospitalization, for another 30 days.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject that was hospitalized with fluid overload and a history of chronic heart failure and CKD stages 1-4
- •Subject has composite congestion score ≥
- •Baseline systolic blood pressure at rest of ≥100mmHg.
- •Subject is capable of meeting the following study requirements:
- •For patients with BMI <30 kg/m2: baseline NT-pro BNP>1,600 pg/ml
- •For patients with BMI >30 kg/m2: baseline NT-pro BNP >800 pg/ml
- •For patients with rate-controlled persistent or permanent AF: NT-pro BNP >2,400 pg/ml.
- •Subject successfully completes 2-4 hours of run-in acclimation session
- •Minimal sweat rate in the last hour of run-in acclimatization of 130gr/hours
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
Average Sweat Rate Per Hour per patient
时间窗: 30 days
An average sweat rate of 150 ml/hr per patient at hospital and at home
Incidence of device- and procedure-related side-effects
时间窗: 30 days
Incidences of system and treatment-related AEs and SAEs including symptomatic changes in vital signs
次要结局
- Incidence of worsening renal function(30 days)
- Changes in congestion score(30 days)
- Changes in Diuretics Dose(30 days)
- Fluid Overload Related Hospitalizations(30 days)
- Change of quality of life(30 days)
- Changes in NT-ProBNP levels(30 days)
- Change in body weight(30 days)