A Multi-centre, Prospective, Open Label, Uncontrolled Pilot Study to Assess the Feasibility and Tolerability of an Automated Continual Water Removal System in Patients With Advanced Diuretic Resistant Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 3
- 主要终点
- Analysis of AEs related to the device and its function.
研究概览
简要总结
This study will assess the functionality and tolerability of an automated continual water removal system in up to 8 patients with HF and diuretic resistance.
intervention: Implanted absorption chamber, connected to an external pump. Follow up: 3 months post activation.
详细描述
Study Duration: 24 months Enrolment 20 months, Follow-up 3 months, Close-out 1 month Study Centres Up to 4 centres with Medical University Wroclaw, Poland, as the principal site.
Objectives: To assess the feasibility, tolerability and functionality of an intra-peritoneal, mechanically induced, ultrafiltration system, through the analysis of procedure and device related serious adverse events and device function.
Number of Subjects: Up to 8 Diagnosis and Main Inclusion Criteria: Patients with fluid overloaded congested heart failure (NYHA Class II-IV) with diuretic resistance and a history of multiple heart failure related admissions.
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 the external fluid drainage bag.
Statistical Methodology: No statistical hypothesis is proposed. Safety will be evaluated using a complete description of Serious Adverse Events. A descriptive analysis will be performed for all primary and secondary variables of the study for the basal measures and all post-basal measures.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 21 years of age
- •Life expectancy > 6 months
- •HF, 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 (eg. Furosemide and Metolazone)
- •Eligible for general anaesthesia and laparoscopic procedure
- •Able to give written informed consent
- •Ability to comply with study procedures and ability to operate the device
- •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 history, or with indication for, mechanical circulatory support
- •iv inotropes required in last 3 months (INTERMACS Score ≤3)
- •Immunocompromised (e.g. chronic steroid treatment, HIV, etc.)
- •Insulin dependent diabetes
- •Severe hyponatraemia as defined by a serum Sodium < 120 mmol/l
- •Serum Albumin < 2.5 g/dL
- •eGFR < 25 ml/min/1.73m2 by MDRD method
- •Previous significant intraabdominal surgery, severe abdominal adhesions, intra-abdominal foreign body (except for small inguinal mesh)
- •Large diaphragmatic hernia, or surgically irreparable, complex or recurring hernia
- •6 minutes' walk test of less than 100 meter
- •History (>6 months) of diaphragmatic hernia, inflammatory or ischemic bowel disease and frequent episodes of diverticulitis
- •Gastrointestinal haemorrhage within the last 4 months
- •Bacterial peritonitis episode within the last 24 months
- •> 2 systemic or local infections, such as urinary tract infection or abdominal skin infection within the last 6 months
- •Liver cirrhosis
- •BMI > 40 presenting a risk for surgery
- •Patients with contraindications for general anaesthesia or laparoscopic surgery
- •Unsuitability for self-maintenance of the experimental home set-up
- •Presence of any current cancer
- •Presence of any active implantable or body-worn devices that cannot be removed excluding ICD / pacemaker
- •Pregnancy
- •Patients being in another therapeutic clinical study
研究组 & 干预措施
Implanted device
Implantation and activation of an automated continual water removal system, including 4-months follow up
干预措施: automated continual water removal system (Device)
结局指标
主要结局
Analysis of AEs related to the device and its function.
时间窗: 4 months
Analysis of incidence and severity of AEs related to the device and its function.
Analysis of AEs related to implantation
时间窗: 4 months
Analysis of incidence and severity of AEs that occur during or following implantation and are related to it.
次要结局
- Functionality(4 months)
- Nocturnal dyspnea score(4 months)
- 6 minutes' walk test(4 months)
- Echocardiographic assessment of LVESD, LVEDD, and LVEF(4 months)
- Clinical assessment of fluid overload(4 months)
- Quality of life questionnaire(4 months)
- NT-proBNP(4 months)
- Serum Creatinine(4 months)
- Serum / urine electrolytes levels.(4 months)