Clinical trial NCT05140759: An Automated Continual Water Removal System in Patients With Advanced Diuretic Resistant Heart Failure
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Paragate Medical LTD
Sponsor class: INDUSTRY
First posted: 2021-12-01
Enrollment: 3
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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

Primary outcomes:
measure: Analysis of AEs related to implantation
timeFrame: 4 months
measure: Analysis of AEs related to the device and its function.
timeFrame: 4 months
Secondary outcomes:
measure: Functionality
timeFrame: 4 months
measure: Clinical assessment of fluid overload
timeFrame: 4 months
measure: Echocardiographic assessment of LVESD, LVEDD, and LVEF
timeFrame: 4 months
measure: Quality of life questionnaire
timeFrame: 4 months
measure: Nocturnal dyspnea score
timeFrame: 4 months
measure: 6 minutes' walk test
timeFrame: 4 months
measure: NT-proBNP
timeFrame: 4 months
measure: Serum Creatinine
timeFrame: 4 months
measure: Serum / urine electrolytes levels.
timeFrame: 4 months
Other outcomes:
Locations:
city: Kutaisi
country: Georgia
facility: West Georgian Medical Center
city: Haifa
country: Israel
facility: Rambam medical center
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego
Study officials:
affiliation: Rambam Health Care Campus
name: Aharon Abbo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego, ul. Borowska 213, 50-556 Wrocław
name: Robert Zymlinski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: West Georgian Medical Center
name: Paata Meshveliani, MD
role: PRINCIPAL_INVESTIGATOR
References: