Status:

RECRUITING

ZeroHeart Biopsy - Prediction of Deceased Donor Heart Transplant Performance From Organ Donors Using Pre-Transplant Biopsies - A Pilot Study

Lead Sponsor:

Medical University of Vienna

Collaborating Sponsors:

Alberta Transplant Applied Genomics Centre

Conditions:

Heart Transplantation

Graft Rejection

Eligibility:

All Genders

Brief Summary

The goal of this observational study is to evaluate whether molecular analysis of donor heart biopsies taken at the time of organ removal ("Time Zero") can help predict the future function and rejecti...

Eligibility Criteria

Inclusion

  • All hearts from standard and expanded criteria donors as well as donor hearts from Donation after circulatory death (DCD) undergoing a heart biopsy at pre-implantation (at procurement) will be included. Consent will be obtained from the recipient at the time of transplant listing.

Exclusion

  • Hearts will be excluded from the study if the participating clinician decides to discard the organ before transplantation or the recipient declines that the biopsy will be performed at the organ procurement.

Key Trial Info

Start Date :

May 12 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 31 2028

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT06982404

Start Date

May 12 2025

End Date

May 31 2028

Last Update

May 21 2025

Active Locations (1)

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Medical University Vienna

Vienna, Vienna, Austria, 1090