NCT05140759

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Feb 2022

Geographic Reach
3 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

February 24, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2024

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

1.9 years

First QC Date

November 9, 2021

Last Update Submit

January 17, 2024

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

  • Analysis of AEs related to implantation

    Analysis of incidence and severity of AEs that occur during or following implantation and are related to it.

    4 months

  • Analysis of AEs related to the device and its function.

    Analysis of incidence and severity of AEs related to the device and its function.

    4 months

Secondary Outcomes (9)

  • Functionality

    4 months

  • Clinical assessment of fluid overload

    4 months

  • Echocardiographic assessment of LVESD, LVEDD, and LVEF

    4 months

  • Quality of life questionnaire

    4 months

  • Nocturnal dyspnea score

    4 months

  • +4 more secondary outcomes

Study Arms (1)

Implanted device

EXPERIMENTAL

Implantation and activation of an automated continual water removal system, including 4-months follow up

Device: automated continual water removal system

Interventions

automated continual water removal systemDEVICE

The device removes excess fluids in heart failure patients with diuretic resistance

Implanted device

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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
  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

West Georgian Medical Center

Kutaisi, 4600, Georgia

Location

Rambam medical center

Haifa, Israel

Location

Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego

Wroclaw, 50-556, Poland

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Aharon Abbo, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

  • Robert Zymlinski, MD

    Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego, ul. Borowska 213, 50-556 Wrocław

    PRINCIPAL INVESTIGATOR

  • Paata Meshveliani, MD

    West Georgian Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2021

First Posted

December 1, 2021

Study Start

February 24, 2022

Primary Completion

January 17, 2024

Study Completion

January 17, 2024

Last Updated

January 19, 2024

Record last verified: 2024-01

Locations

PL(1)GE(1)IL(1)