NCT03991923

Non-ischemic Preservation of the Donor Heart in Heart Transplantation

Active, enrolled NA Last updated 4 April 2025

What this trial tests

NA trial testing XVIVO heart preservation devices in Heart Transplantation in 230 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

25 November 2020

Primary endpoint
31 August 2023

31 December 2028

Quick facts

Lead sponsor	XVIVO Perfusion
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	230
Start date	25 November 2020
Primary completion	31 August 2023
Estimated completion	31 December 2028
Sites	15 locations across France, Italy, Belgium, Austria, Sweden, United Kingdom, Germany, Spain

Drugs / interventions tested

• XVIVO heart preservation devices
• Standard ICSS

Conditions studied

• Heart Transplantation — all drugs for Heart Transplantation →

Sponsor

XVIVO Perfusion — full company profile →

Who can join

Adults 18 to 70, any sex, with Heart Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Machine Perfusion for Human Heart Preservation: A Systematic Review.
   Qin G, Jernryd V, Sjöberg T, Steen S, et al · · 2022 · cited 57× · PMID 35401041 · DOI 10.3389/ti.2022.10258
2. Hypothermic oxygenated perfusion of the donor heart in heart transplantation: the short-term outcome from a randomised, controlled, open-label, multicentre clinical trial.
   Rega F, Lebreton G, Para M, Michel S, et al · · 2024 · cited 50× · PMID 39153817 · DOI 10.1016/s0140-6736(24)01078-x
3. Pushing the boundaries of innovation: the potential of <i>ex vivo</i> organ perfusion from an interdisciplinary point of view.
   Iske J, Schroeter A, Knoedler S, Nazari-Shafti TZ, et al · · 2023 · cited 21× · PMID 37900569 · DOI 10.3389/fcvm.2023.1272945
4. Heart graft preservation technics and limits: an update and perspectives.
   Ughetto A, Roubille F, Molina A, Battistella P, et al · · 2023 · cited 11× · PMID 38028479 · DOI 10.3389/fcvm.2023.1248606
5. Non-ischaemic preservation of the donor heart in heart transplantation: protocol design and rationale for a randomised, controlled, multicentre clinical trial across eight European countries.
   Brouckaert J, Dellgren G, Wallinder A, Rega F. · · 2023 · cited 9× · PMID 38154894 · DOI 10.1136/bmjopen-2023-073729
6. Clinical Outcomes of Machine Perfusion and Temperature Control Systems in Heart Transplantation: Where We Stand.
   Nasim U, Dorken-Gallastegi A, Dadson P, Hong Y. · · 2025 · cited 5× · PMID 40004682 · DOI 10.3390/jcm14041152
7. Candidate Biomarkers YES1, Troponin I, Lactate, and Ammonia for Evaluation of Cardiac Function Post Hypothermic Oxygenated Perfusion.
   Ballan EM, Vervoorn MT, Kaffka Genaamd Dengler SE, Marsman J, et al · · 2025 · cited 2× · PMID 40131761 · DOI 10.1097/mat.0000000000002419
8. The thoracic surgeon perspective-lung transplantation in controlled donation after circulatory determination of death: any conflict with the heart?
   Van Raemdonck D, Brouckaert J, Van Slambrouck J, Vandendriessche K, et al · · 2024 · cited 1× · PMID 39649632 · DOI 10.21037/acs-2024-dcd-0032