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ACTIVE NOT RECRUITING
NCT03991923
NA

Non-ischemic Preservation of the Donor Heart in Heart Transplantation

Sponsor: XVIVO Perfusion

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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