Barcelona Clinical Coordinating Center (BCCC), serving as the European Authorized
Representative of Revamp Medical Inc. and responsible for the coordination of study
activities in Spain, announces the successful completion of the DORAYA-HF OUS EFS
study evaluating the safety, feasibility, and clinical performance of the Doraya Catheter for
the treatment of volume overload in patients hospitalized with acute decompensated heart
failure who have shown an inadequate response to intravenous diuretic therapy.
This prospective, multicenter, single-arm clinical investigation assessed the Doraya
Device, an innovative device designed to temporarily regulate inferior vena cava flow with
the aim of reducing venous congestion and improving diuretic response. The study
successfully enrolled 25 patients across 10 centers in Europe, generating valuable
clinical evidence to support the future development of this promising therapeutic approach
for complex heart failure management.
In Spain, BCCC coordinated study operations at four participating hospitals: Hospital
Clínic de Barcelona, Hospital Universitari Vall d’Hebron, Hospital Clínico Universitario de
Valencia, and Hospital Clínico Universitario de Valladolid. Spanish sites contributed five
enrolled patients. The successful completion of recruitment highlights the strong
commitment and collaboration among investigators, clinical sites, the Sponsor, and BCCC
in its dual role as European Authorized Representative and coordinating CRO for Spain.
“The successful completion of this international clinical study represents an important
milestone in the advancement of novel therapeutic strategies for patients with complex
acute heart failure. At BCCC, we are particularly proud of our contribution as Authorized
Representative in Europe and of our coordination in the clinical execution of this innovative
research program” said Dr. Josep Rodés-Cabau (Chief Scientific Officer at BCCC).
About Revamp Medical Inc.
Revamp Medical Inc. is a medical device company focused on developing innovative
technologies for the treatment of acute heart failure and related cardiovascular conditions.
The company is committed to advancing novel therapeutic solutions designed to address
unmet clinical needs and improve patient outcomes.
About Barcelona Clinical Coordinating Center (BCCC)
Barcelona Clinical Coordinating Center is a non-profit CRO specializing in the coordination
and management of clinical research projects, providing expertise in trial design, site
management, data coordination, as well as regulatory and statistical support.
