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An Automated Continual Water Removal System in Patients With Advanced Diuretic Resistant Heart Failure (ACWR-HF)

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
automated continual water removal system
Sponsored by
Paragate Medical LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • West Georgian Medical Center
  • Rambam medical centerRecruiting
  • Uniwersytecki Szpital Kliniczny im Jana Mikulicza-RadeckiegoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implanted device

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Functionality
Assessed by a daily volume of fluid removal
Clinical assessment of fluid overload
Fluid retention measures such as pitting oedema, jugular distention, body weight elevation
Echocardiographic assessment of LVESD, LVEDD, and LVEF
Data from echocardiography will enable the provision of volumes, diastolic function, right ventricular function, hemodynamics, and valvular regurgitation. This versatile tool is employed vastly for the management of heart failure. LVEF - Left Ventricular Ejection Fraction LVESD -Left Ventricular End-Systolic Diameters LVEDD - Left Ventricular external end-diastolic diameter
Quality of life questionnaire
KCCQ-12 questionnaire The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Nocturnal dyspnea score
Will be assessed using the following questions: Has the patient ever woken up at night with shortness of breath? How long after lying down did the episode occur? Number of pillows used under the patient's head at night: Has the patient ever had to sleep sitting up? Has the patient developed coughing or wheezing in the recumbent position? What did the patient do to relieve his distress? Please specify.
6 minutes' walk test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
NT-proBNP
NT-proBNP is a marker for HF severity.
Serum Creatinine
A marker for kidney function.
Serum / urine electrolytes levels.
Electrolyte and metabolite disorders indicate on kidney function. hypercalcemia /hypocalcemia. hyperchloremia /hypochloremia. hypermagnesemia /hypomagnesemia. hyperphosphatemia /hypophosphatemia. hyperkalemia /hypokalemia. hypernatremia /hyponatremia.

Full Information

First Posted
November 9, 2021
Last Updated
July 13, 2023
Sponsor
Paragate Medical LTD
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1. Study Identification

Unique Protocol Identification Number
NCT05140759
Brief Title
An Automated Continual Water Removal System in Patients With Advanced Diuretic Resistant Heart Failure
Acronym
ACWR-HF
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Paragate Medical LTD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Implanted device
Arm Type
Experimental
Arm Description
Implantation and activation of an automated continual water removal system, including 4-months follow up
Intervention Type
Device
Intervention Name(s)
automated continual water removal system
Intervention Description
The device removes excess fluids in heart failure patients with diuretic resistance
Primary Outcome Measure Information:
Title
Analysis of AEs related to implantation
Description
Analysis of incidence and severity of AEs that occur during or following implantation and are related to it.
Time Frame
4 months
Title
Analysis of AEs related to the device and its function.
Description
Analysis of incidence and severity of AEs related to the device and its function.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Functionality
Description
Assessed by a daily volume of fluid removal
Time Frame
4 months
Title
Clinical assessment of fluid overload
Description
Fluid retention measures such as pitting oedema, jugular distention, body weight elevation
Time Frame
4 months
Title
Echocardiographic assessment of LVESD, LVEDD, and LVEF
Description
Data from echocardiography will enable the provision of volumes, diastolic function, right ventricular function, hemodynamics, and valvular regurgitation. This versatile tool is employed vastly for the management of heart failure. LVEF - Left Ventricular Ejection Fraction LVESD -Left Ventricular End-Systolic Diameters LVEDD - Left Ventricular external end-diastolic diameter
Time Frame
4 months
Title
Quality of life questionnaire
Description
KCCQ-12 questionnaire The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Time Frame
4 months
Title
Nocturnal dyspnea score
Description
Will be assessed using the following questions: Has the patient ever woken up at night with shortness of breath? How long after lying down did the episode occur? Number of pillows used under the patient's head at night: Has the patient ever had to sleep sitting up? Has the patient developed coughing or wheezing in the recumbent position? What did the patient do to relieve his distress? Please specify.
Time Frame
4 months
Title
6 minutes' walk test
Description
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Time Frame
4 months
Title
NT-proBNP
Description
NT-proBNP is a marker for HF severity.
Time Frame
4 months
Title
Serum Creatinine
Description
A marker for kidney function.
Time Frame
4 months
Title
Serum / urine electrolytes levels.
Description
Electrolyte and metabolite disorders indicate on kidney function. hypercalcemia /hypocalcemia. hyperchloremia /hypochloremia. hypermagnesemia /hypomagnesemia. hyperphosphatemia /hypophosphatemia. hyperkalemia /hypokalemia. hypernatremia /hyponatremia.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Inbal Eyal
Phone
+972543321252
Email
inbal@paragate-medical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nitai Hanani, Msc
Email
clinicaltrials@paragate-medical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Zukerman, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Zymlinski, MD
Organizational Affiliation
Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego, ul. Borowska 213, 50-556 Wrocław
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paata Meshveliani, MD
Organizational Affiliation
West Georgian Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Georgian Medical Center
City
Kutaisi
ZIP/Postal Code
4600
Country
Georgia
Individual Site Status
Active, not recruiting
Facility Name
Rambam medical center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ludmila Helmer, RN
Email
l_helmer@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Natalia Alberkant, RN
Email
anatalia@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Robert Zukerman, MD
Facility Name
Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego
City
Wrocław
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanna Szachniewicz, MD
Email
jszachniewicz@gmail.com
First Name & Middle Initial & Last Name & Degree
Robert Zymlinski

12. IPD Sharing Statement

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An Automated Continual Water Removal System in Patients With Advanced Diuretic Resistant Heart Failure

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