A prospective, multi-national, open-label clinical study which is conducted to asses the safety, feasibility and performance of the TRVD™ System in hospital-admitted patients with Acute Decompensated Heart Failure (ADHF) and evidence of reduced left ventricular ejection fraction. The study will include patients who present with significant venous congestion, as evidenced by clinical, laboratory and imaging signs of fluid retention. Study participation, for each enrolled subject, will last approximately 3 months post index procedure. Patients will be evaluated from enrollment until hospital discharge, then at 30, 60, and 90 days post procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
A catheter-mounted expandable flow pump is to be deployed in a transfemoral venous catheterization procedure. Once in place, renal venous pressure is reduced to a pre-selected physiologic target pressure and kept there for up to 24 hours. After termination of TRVD therapy, the device is removed.
OLV-Hospital Aalst, Belgium
Aalst, Belgium
Clinical Hospital Centre Zagreb
Zagreb, Croatia
Zemun Clinical Hospital Center
Belgrade, Serbia
Preliminary Safety (device- and procedure-related SAEs)
Incidence of device- and procedure-related SAEs
Time frame: 30 days post index procedure
Feasibility (technical success)
Rate of technical success (defined as successful delivery and deployment, adequate function during device operation and successful retrieval) at hospital discharge.
Time frame: Hospital discharge (at least 96 hours following index procedure)
Feasibility (procedural success)
Rate of procedural success (defined as absence of device-related SAEs) at hospital discharge.
Time frame: Hospital discharge (at least 96 hours following index procedure)
Initial performance (effectiveness of renal venous pressure reduction)
Invasively assessed renal venous pressure reduction from baseline (in mmHg)
Time frame: Up to 24 hours
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