The study objective is to evaluate the feasibility of the Doraya Catheter and measure clinical performance and safety endpoints, in ADHF patients deemed to have insufficient diuretic response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Temporary deployment of the Doraya catheter in ADHF patients
Heartcenter Dresden
Dresden, Germany
Klinikum Fürth
Fürth, Germany
UKSH Universitäres Herzzentrum Lübeck
Lübeck, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany
Serious Adverse Events
Device or procedure related SAEs rate (including MACE) based on MM adjudication.
Time frame: 30 day post Doraya procedure
Urine Output
Change in total urine output
Time frame: 24 hours pre Doraya deployment, during Doraya indwelling period, and for 24 hours after Doraya removal
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
A.O.U Pisana Cisanello
Pisa, Italy
Mikulicz-Radecki University Teaching Hospital in Wrocław
Wroclaw, Poland
SUSCCH
Banská Bystrica, Slovakia
CINRE, s.r.o.
Bratislava, Slovakia
Hospital clinic de Barcelona
Barcelona, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain