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Non-ischemic Preservation of the Donor Heart in Heart Transplantation

NCT03991923 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Heart Transplantation

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

Sponsors & Collaborators

  • XVIVO Perfusion

    lead INDUSTRY

Principal Investigators

  • Filip Rega, MD, PhD · UZ Leuven

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-25
Primary Completion
2023-08-31
Completion
2028-12-31

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03991923 on ClinicalTrials.gov