Percutaneously Delivered Automated Continual Fluid Removal System in Patients With Advanced Diuretic-Resistant Heart Failure

Summary

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.

Eligibility

Inclusion Criteria:

* ≥ 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

Exclusion Criteria:

* 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

  * 3), 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

Conditions2

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