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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 6
- 主要终点
- Analysis of AEs related to implantation
研究概览
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.
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
- •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
- •Previous significant intraabdominal surgery, severe abdominal adhesions, intra-abdominal foreign body (except for small inguinal mesh)
- •Current or historical (within last 6 months) large diaphragmatic hernia, or surgically irreparable, complex or recurring hernia
- •6 minutes walk test of less than 100 meters in all repeated testing (if applicable), or similar test
- •Severe, multiple repeated cardiac-related ascites, subject to principal investigator (PI) discretion
- •Inflammatory or ischemic bowel disease (i.e., Crohn's disease, ulcerative colitis) and frequent episodes of diverticulitis
- •Current gastrointestinal active infection in the body (such as Clostridium difficile infection)
- •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
- •Class B or C liver cirrhosis of non-cardiac aetiology
- •18.5 > body mass index (BMI) > 40 presenting a risk for surgery
- •Patients with contraindications for general/local anaesthesia, sedation and
- •or Percutaneous / Laparoscopic surgery
- •Unsuitability for self-maintenance of the experimental home set-up
- •Presence of any current cancer, subject to PI discretion
- •Presence of any active implantable or body-worn devices that cannot be removed excluding Implantable Cardioverter-Defibrillator (ICD) / pacemaker, subject to PI discretion
- •Known hypersensitivity to Nitinol nickel/titanium alloy and brilliant blue
- •Pregnancy
- •Patients being in another therapeutic clinical study
研究组 & 干预措施
Intraperitoneal implanted device
Implantation and activation of an automated continual water removal system
干预措施: Automated Continual Fluid Removal System (Device)
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)