Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-24 @ 2:51 PM
NCT ID:
NCT05140759
Eligibility Criteria:
Inclusion Criteria:
* ≥ 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.
Exclusion Criteria:
* • 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT05140759
Study Brief:
Protocol Section:
NCT05140759