A Multi-Center, Multinational, Prospective, Open-Label, Single Arm, Pilot Study to Assess the Feasibility, Safety and Tolerability of a Percutaneously Delivered Automated Continual Fluid Removal System in Patients With Advanced Diuretic-Resistant Heart Failure
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Heart Failure
- 发起方
- Paragate Medical LTD
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Analysis of AEs related to implantation
- 状态
- 招募中
- 最后更新
- 9个月前
概览
简要总结
The study aims to assess the feasibility, safety, tolerability and functionality of a percutaneously delivered automated continual fluid removal System in up to 8 patients with Heart Failure (HF) and diuretic resistance.
Intervention: Implanted absorption chamber, connected to an external pump. Follow up: 6 months post activation.
详细描述
Objectives: To assess the feasibility, safety, tolerability and functionality of an intra-peritoneal, mechanically induced ultrafiltration system (IPUDx), through the analysis of procedure and device related serious adverse events and device function. Study Duration: Up to 24 months. Enrolment 15 months, Activation following implantation (per patient) up to 1 month, Follow-up (per patient) 6 months, Close-out 2 months. Number of Subjects: Up to 8 Diagnosis and Main Inclusion Criteria: Patients with fluid overloaded congested heart failure (The New York Heart Association Class II-IV) with diuretic resistance and a history of multiple heart failure related admissions. Study Centers: Up to 5 Medical Centers in Serbia and Spain. Study Product and Planned Use: The Paragate Medical IPUDx System comprises an intraperitoneally implanted fluid absorption chamber with an external wearable rechargeable pump, drainage bag and controller. The system induces isotonic fluid loss across the peritoneal membranes which is collected in the fluid absorption chamber and transported to a daily disposable external fluid drainage bag. Statistical Methodology: No statistical hypothesis is proposed. Safety will be evaluated using a complete description of Serious Adverse Events (SAEs). A descriptive analysis will be performed for all primary and secondary variables of the study for the basal measures and all post-basal measures. Interim analysis for all the study endpoints will be performed at the completion of the active follow up phase (3 months post activation). Safety analysis for Adverse Device Effects (ADEs) will be performed both at 3-month post activation and at the completion of maintenance phase (6 months post implantation).
研究者
入排标准
入选标准
- •≥ 21 years of age
- •Life expectancy \> 6 months
- •Heart Failure, New York Heart Association (NYHA) class II-IV
- •\> 1 HF related admissions in the last 12 months
- •Fluid congestion (2 signs of pitting oedema, jugular distention, BW elevation, nocturnal dyspnoea score, respiration rate, pulmonary congestion and/or pleural effusion per chest x-ray, ascites)
- •Failure to achieve effective diuresis and congestion relief despite appropriate or escalating diuretic doses or combination of diuretics
- •Able to give written informed consent
- •Ability to comply with study procedures and ability to operate the device themselves or by a regular caregiver support
- •Residence in proximity to the medical center to ensure easy access for required hospital visits and to enable home visits
- •Women of childbearing potential should use adequate contraception for as long as the device is implanted
排除标准
- •Any non-cardiac disease with life expectancy \< 1 year
- •Any patient listed for solid organ transplantation
- •Patients with a history, or with an indication for mechanical circulatory support
- •intravenous (IV) inotropes required in last 3 months (INTERMACS Score
- •, excluding Levosimendan
- •Immunocompromised (e.g. chronic steroid treatment, Human immunodeficiency virus (HIV), etc.)
- •Insulin dependent diabetes with evidence of infection
- •Severe hyponatremia as defined by a serum Sodium \< 120 mmol/l
- •Serum Albumin \< 2.5 g/Dl
- •Glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2 by MDRD method, using MDRD 4-variable equation that includes age, sex, ethnicity, and serum creatinine
结局指标
主要结局
Analysis of AEs related to implantation
时间窗: 3 months post activation
based on analysis of the incidence of serious adverse events related to the implantation procedure.
Serious Adverse Events related to the device
时间窗: 3 months post activation and 6 months from implantation
Based on the incidence of serious adverse events related to the device
Successful Implantation Rate
时间窗: 3 months post activation
based on post-insertion imaging confirmation utilizing imaging modalities such as X-rays to confirm the appropriate placement and positioning of the chamber within the peritoneal cavity (appropriate placement yes/no)
次要结局
- Device Functionality(3 months post activation)
- Clinical assessment of fluid overload(3 months post activation)
- Effectiveness of the drainage fluid(3 months post activation)
- Echocardiographic assessment(3 months post activation)
- Quality of life questionnaire (KCCQ-12 questionnaire)(3 months post activation)
- Markers of heart failure Severity:(3 months post activation)
- 6 minutes' walk test(3 months post activation)
- Number of HF congestion related hospital admissions(3 months post activation)
- Dyspnoea Score(3 months post activation)
- Levels of Serum Creatinine(3 months post activation)
- Electrolytes levels(3 months post activation)