Non-ischemic Preservation of the Donor Heart in Heart Transplantation

April 16, 2026 updated by: XVIVO Perfusion

Non-ischemic Preservation of the Donor Heart in Heart Transplantation - a Randomized, Controlled, Multicenter Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will investigate if non-ischemic heart preservation (NIHP) with the XVIVO heart preservation devices could improve clinical outcome of patients receiving hearts after use of the technology compared to after use of standard cold ischemic preservation. This will be investigated in a European multicentre randomized controlled clinical trial. For technical reasons, blinding to the involved clinical personnel is not possible, however, biopsies will be blinded to study pathologists. The trial will include 202 recipients that have been randomized through their heart donor. The primary outcome of the study is a clinically relevant composite including graft survival, primary graft dysfunction, rejection and use of circulatory mechanical support, within 30 days and also including Cardiac Allograft Vasculopathy within 12 months. As secondary outcomes, molecular markers related to cardiac injury CKMB, ProBNP and TNI will be investigated as well as markers of the inflammatory response. Safety aspects such as effect on other organs and machine defects will also be monitored. The study population is adults, listed for heart transplantation and donors accepted as heart donors according to standard hospital procedures. Specific recipient exclusion criteria related to pre-transplant ECMO support, patients undergoing pre-transplant desensitization protocol, patients with Grown-Up Congenital Heart Disease, patients with severe kidney or liver dysfunction, patients with septicaemia, and patients diagnosed with Systemic Lupus Erythematous, sarcoidosis or amyloidosis are excluded. Cardiac death donors and donors with previous sternotomy are excluded. The study hypothesis is that NIHP better preserves the endothelium and myocyte function of the heart resulting in improved short- and medium-term recipient outcome, without inducing any new significant risks to the retrieved heart or the recipient. This is believed to be accomplished through continuous oxygenation of the heart via perfusion of the coronary arteries using an optimized preservation solution, mimicking the normal environment for the endothelium.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria
        • Allgemeines Krankenhaus der Stadt Wien
  • Belgium
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • UZ Leuven
  • France
      • Paris, France
        • Hopital Bichat Claude-Bernard
    • Paris Cedex
      • Paris, Paris Cedex, France, 75651
        • Institut de cardiologie, Chirurgie thoracique et cardiovasculaire La Pitié Salpetrière
  • Germany
      • Bad Oeynhausen, Germany
        • Universitätsklinik Der Ruhr-Universität Bochum
      • Düsseldorf, Germany
        • Universitätsklinikum Düsseldorf
      • Hanover, Germany
        • Hannover Medical School
    • Bavaria
      • München, Bavaria, Germany, 81377
        • Klinikum der Universität München
    • Brandenburg
      • Berlin, Brandenburg, Germany, 13353
        • Deutschen Herzzentrum Berlin
  • Italy
    • Padova PD
      • Padova, Padova PD, Italy, 35121
        • Azienda osedalaria di Padova
  • Spain
    • Majadahonda Madrid
      • Madrid, Majadahonda Madrid, Spain, 28222
        • Hospital Puerto de Hierro
  • Sweden
    • Västra Götalands Regionen
      • Gothenburg, Västra Götalands Regionen, Sweden, 412 34
        • Sahlgrenska University Hospital
  • United Kingdom
      • Birmingham, United Kingdom, B152TH
        • Queen Elisabeth Hospital
      • Cambridge, United Kingdom
        • Royal Papworth Hospital
    • Newcastle Upon Tyne
      • Newcastle, Newcastle Upon Tyne, United Kingdom, NE77DN
        • Freeman Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria recipient:

  • Age ≥18 years
  • Signed informed consent form
  • Listed for heart transplantation

Inclusion criteria donor:

  • Age ≥18 and ≤70 years
  • Accepted as heart donor by the transplant team
  • (Research consent from the donor if required in country)

Exclusion Criteria recipient:

  • Previous solid organ transplantation
  • Grown-up congenital heart disease (GUCH)
  • Kidney failure eGFR<40 at listing, calculated by CDK-EPI Creatinine, or ultrafiltration or dialysis or rapidly deteriorating kidney function due to a diagnosed renal disease
  • Coagulopathy due to known hepatic disease or heparin induced thrombocytopenia
  • Subject diagnosed with Systemic Lupus Erythematous, sarcoidosis or amyloidosis
  • Known ongoing septicemia defined as positive blood culture immediately prior to the transplant (including with a durable VAD)
  • Incompatible blood group
  • Not able to understand the information provided during the informed consent procedure
  • Combined organ transplantation candidates
  • Subject already enrolled in another transplant related intervention study
  • Subjects under pre-transplant desensitization protocol (including plasma exchange in conjunction with the transplant surgery)
  • Mechanical circulatory support pre-transplantation (except durable Left ventricular assist device or Intra-aortic balloon pump)

Exclusion criteria donor:

  • Previous sternotomy
  • DCD hearts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Non-ischemic heart preservation (NIHP)
Continous cold cardioplegic perfusion of hearts
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.
Active Comparator: Ischemic cold static storage (ICSS)
Standard preservation technique
Device: Standard ICSS
Cold static preservation using standard preservation solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
30 days mortality and 30 days graft dysfunction
Time Frame: 30 days
The Primary End-Point is defined as time-to-first-event of cardiac related death, moderate or severe primary graft dysfunction of the left ventricle or primary graft dysfunction of the right ventricle (according to Kobashigawa et al., 2014), acute cellular rejection ≥2R (according to Stewart et al., 2005) or graft failure (use of mechanical circulatory support or retransplantation) within 30 days.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
1 year mortality and 1 year graft dysfunction
Time Frame: 1 year
The key secondary endpoint is defined as time-to-first-event of either any cause of death, moderate or severe PGD-LV or PGD-RV (according to Kobashigawa et al., 2014), acute cellular rejection ≥2R (according to Stewart et al., 2005) or graft failure (use of mechanical circulatory support or retransplantation) or CAV ≥ 1 (according to Mehra, 2010) within 12 months.
1 year
30 days and 1 year mortality and graft dysfunction
Time Frame: 30 days and 1 year
The individual variables included in the composite primary endpoint at 30 days and 1 year analyzed as time-to-first-event.
30 days and 1 year
CKMB
Time Frame: 3 days
Creatine kinase MB (CKMB) at 6 ±2 h, 24 ±6 h, 48±6 h and 72±6 h after cross clamp removal
3 days
TnI
Time Frame: 3 days
Tropinin I (TnI) at 6 ±2 h, 24 ±6 h, 48±6 h and 72±6 h after cross clamp removal
3 days
ProBNP
Time Frame: 3 days
Pro Brain Natriuretic Protein (ProBNP) at 6 ±2 h, 24 ±6 h, 48±6 h and 72±6 h after cross clamp removal
3 days
Stay in ICU
Time Frame: 1 year
Length of Stay at Intensive Care Unit, reported as number of days
1 year
Cardiac Transplant Events
Time Frame: 1 year
Incidence of Major Adverse Cardiac Transplant Events
1 year
Postoperative use of mechanical circulatory support
Time Frame: 1 year
Incidence of use of postoperative mechanical circulatory support, reported as number of days
1 year
Postoperative duration of mechanical circulatory support
Time Frame: 1 year
Duration of use of postoperative mechanical circulatory support, reported as number of days
1 year
Overall success/failure 30 days
Time Frame: 30 days
Success is defined as a recipient that are transplanted and alive at 30 days without any of the complication in the primary endpoint before 30 days.
30 days
Overall success/failure 1 year
Time Frame: 1 year
Success is defined as a recipient that are transplanted and alive at 1 year without any of the complication given in key secondary endpoint before 1 year.
1 year
ECHO data (Left ventricular ejection fraction)
Time Frame: 24 hours
ECHO data with Left ventricular ejection fraction in percentage within 24 hours after transplantation
24 hours
ECHO data (Left ventricular ejection fraction)
Time Frame: 1 week
ECHO data with Left ventricular ejection fraction in percentage 1 week after transplantation
1 week
ECHO data (Left ventricular ejection fraction)
Time Frame: 6 months
ECHO data with Left ventricular ejection fraction in percentage 6 months after transplantation
6 months
ECHO data (Left ventricular ejection fraction)
Time Frame: 1 year
ECHO data with Left ventricular ejection fraction in percentage 1 year after transplantation
1 year
ECHO data (Right ventricular ejection fraction)
Time Frame: 24 hours
ECHO data with Right ventricular ejection fraction in percentage within 24 hours after transplantation
24 hours
ECHO data (Right ventricular ejection fraction)
Time Frame: 1 week
ECHO data with Right ventricular ejection fraction in percentage 1 week after transplantation
1 week
ECHO data (Right ventricular ejection fraction)
Time Frame: 6 months
ECHO data with Right ventricular ejection fraction in percentage 6 months after transplantation
6 months
ECHO data (Right ventricular ejection fraction)
Time Frame: 1 year
ECHO data with Right ventricular ejection fraction in percentage 1 year after transplantation
1 year
ECHO data (Tricuspid annular plane systolic excursion)
Time Frame: 24 hours
ECHO data with Tricuspid annular plane systolic excursion (TAPSE) in mm within 24 hours after transplantation
24 hours
ECHO data (Tricuspid annular plane systolic excursion)
Time Frame: 1 week
ECHO data with Tricuspid annular plane systolic excursion (TAPSE) in mm 1 week after transplantation
1 week
ECHO data (Tricuspid annular plane systolic excursion)
Time Frame: 6 months
ECHO data with Tricuspid annular plane systolic excursion (TAPSE) in mm 6 months after transplantation
6 months
ECHO data (Tricuspid annular plane systolic excursion)
Time Frame: 1 year
ECHO data with Tricuspid annular plane systolic excursion (TAPSE) in mm 1 year after transplantation
1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serious adverse device effects
Time Frame: 1 year
Incidence of any serious adverse device effects.
1 year
Adverse device effects
Time Frame: 1 year
Incidence of any adverse device effects
1 year
Device dysfunction resulting in loss of transplantable heart
Time Frame: 12 hours
Number of transplantable hearts lost due to device dysfunction
12 hours
Intra operative details; duration of ECC
Time Frame: 12 hours
Duration of ECC in minutes
12 hours
Intra operative details; duration of cross clamp
Time Frame: 12 hours
Duration of cross clamp in minutes
12 hours
Intra operative details; duration of surgery
Time Frame: 12 hours
Duration of surgery in minutes
12 hours
Intra operative details; attempts to wean off ECC
Time Frame: 12 hours
Number of attempts to wean off ECC
12 hours
Intra operative details; need for inotropic support
Time Frame: 12 hours
Need for inotropic support (inotropic score)
12 hours
Intra operative details; need for pulmonary vasodilator
Time Frame: 12 hours
Need for pulmonary vasodilator
12 hours
Intra operative details; defibrillations
Time Frame: 12 hours
Number of defibrillations
12 hours
Intra operative details; arryhythmias
Time Frame: 12 hours
Occurence of arryhythmias
12 hours
Intra operative details; conduction abnormalities
Time Frame: 12 hours
Number of conduction abnormalities
12 hours
Intra operative details; Left ventricular ejection fraction (LVEF)
Time Frame: 12 hours
LVEF in percentage
12 hours
Intra operative details; Right ventricular ejection fraction (RVEF)
Time Frame: 12 hours
RVEF in percentage
12 hours
Intra operative details; Mitral valve regurgitations
Time Frame: 12 hours
Grade of mitral valve regurgitations
12 hours
Intra operative details; Tricuspid valve regurgitations
Time Frame: 12 hours
Occurence of tricuspid vavle regurgitations
12 hours
Arterial blood gas lactate
Time Frame: 6 hours
Arterial blood gas lactate at 6 hours
6 hours
Arterial blood gas lactate
Time Frame: 24 hours
Arterial blood gas lactate at 24 hours
24 hours
Pro-BNP during follow up
Time Frame: 1 year
Pro-BNP at predefined time points during follow-up.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
XVIVO Perfusion

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Filip Rega, MD, PhD, UZ Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIHP2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Transplantation

Clinical Trials on XVIVO heart preservation devices

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings