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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
The device removes excess fluids in heart failure patients with diuretic resistance
West Georgian Medical Center
Kutaisi, Georgia
Rambam medical center
Haifa, Israel
Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego
Wroclaw, Poland
Analysis of AEs related to implantation
Analysis of incidence and severity of AEs that occur during or following implantation and are related to it.
Time frame: 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.
Time frame: 4 months
Functionality
Assessed by a daily volume of fluid removal
Time frame: 4 months
Clinical assessment of fluid overload
Fluid retention measures such as pitting oedema, jugular distention, body weight elevation
Time frame: 4 months
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
Time frame: 4 months
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.
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Time frame: 4 months
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.
Time frame: 4 months
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.
Time frame: 4 months
NT-proBNP
NT-proBNP is a marker for HF severity.
Time frame: 4 months
Serum Creatinine
A marker for kidney function.
Time frame: 4 months
Serum / urine electrolytes levels.
Electrolyte and metabolite disorders indicate on kidney function. hypercalcemia /hypocalcemia. hyperchloremia /hypochloremia. hypermagnesemia /hypomagnesemia. hyperphosphatemia /hypophosphatemia. hyperkalemia /hypokalemia. hypernatremia /hyponatremia.
Time frame: 4 months