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Non-ischemic Preservation of the Donor Heart in Heart Transplantation
Sponsor: XVIVO Perfusion
Summary
The study intends to compare standard ischemic cold static storage (ICSS) of retrieved hearts intended to be transplanted, to non-ischemic heart preservation (NIHP) in a randomized clinical multicentre trial. The primary hypothesis is that the non-ischemic hypothermic cardioplegic preservation (NIHP) is safe and superior to ischemic cold static storage (ICSS) of donor hearts. The study will investigate the safety and superiority of the new methodology in terms of improved immediate and prolonged organ function in adult heart transplanted patients.
Official title: Non-ischemic Preservation of the Donor Heart in Heart Transplantation - a Randomized, Controlled, Multicenter Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
230
Start Date
2020-11-25
Completion Date
2028-12-31
Last Updated
2025-04-04
Healthy Volunteers
No
Conditions
Interventions
XVIVO heart preservation devices
The intervention is to preserve hearts during transportation cold, cardioplegic and non-ischemic, with a high oncotic and hormone supplemented perfusate.
Standard ICSS
Cold static preservation using standard preservation solution
Locations (15)
Allgemeines Krankenhaus der Stadt Wien
Vienna, Austria
UZ Leuven
Leuven, Flemish Brabant, Belgium
Institut de cardiologie, Chirurgie thoracique et cardiovasculaire La Pitié Salpetrière
Paris, Paris Cedex, France
Hôpital Bichat Claude-Bernard
Paris, France
Klinikum der Universität München
München, Bavaria, Germany
Deutschen Herzzentrum Berlin
Berlin, Brandenburg, Germany
Universitätsklinik der Ruhr-Universität Bochum
Bad Oeynhausen, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Hannover Medical School
Hanover, Germany
Azienda osedalaria di Padova
Padova, Padova PD, Italy
Hospital Puerto de Hierro
Madrid, Majadahonda Madrid, Spain
Sahlgrenska University Hospital
Gothenburg, Västra Götalands Regionen, Sweden
Freeman Hospital
Newcastle, Newcastle upon Tyne, United Kingdom
Queen Elisabeth Hospital
Birmingham, United Kingdom
Royal Papworth Hospital
Cambridge, United Kingdom