The study is intended to verify the safety and assess the performance of up to 3-days treatment protocol with the RenaSense System in ADHF patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
RenaSense Catheter, Electrical Stimulation of the Urinary Bladder Wall
RenaSense Catheter,no delivery of stimulation
Rambam Health Care Campus
Haifa, Outside USA, Israel
Hillel Yaffe Medical Center
Hedera, Israel
Ziv Medical Center
Safed, Israel
Number of Participants with unanticipated adverse events as a measure of safety and tolerability
Time frame: 72 hours
Renal Function as Assessed by Serum Cystatin C level
Time frame: 24, 48 and 72 hours
Urinary symptoms, hospitalizations and mortality
Assess no increase in urinary symptoms of obstruction or incontinence, hospitalizations and mortality rates following 30 days and 90 days follow-up, as compared to control with no electrical stimulation treatment
Time frame: 90 days
Sum of Global Rank Score following 72 hours of treatment as compared to baseline
Time frame: 72 hours
Urine volume
Urine output volume collected over 24 hour intervals during days 1 to 3 of treatment
Time frame: 24, 48 and 72 hours
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