WithdrawnNot Applicable

Donor-Derived Cell-free DNA to DETect REjection in Cardiac Transplantation

Stopped: Sponsor made decision to pause study while it was still in development phase. The FDA and IRB approval process had not been completed. No sites were activated. No subjects had been recruited for this study.

0Started 2023-01

Plain-language summary

The study objective is to demonstrate that rejection surveillance of heart transplant recipients with Prospera dd-cfDNA is non-inferior to rejection surveillance with endomyocardial biopsy and histology in the first post-transplant year.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female, age 18 years or older at the time of signing informed consent.
✓. On the heart transplant waiting list and expected to receive a heart transplant.
✓. Able to read, understand and provide written informed consent.
✓. Able and willing to comply with the study visit schedule, study procedures and study requirements.

Exclusion criteria

✕. Heart transplantation has been performed.
✕. Concurrent multiple solid organ or tissue transplant
✕. Prior history of any organ or cellular transplantation.
✕. Planned use of other commercially available or investigational cfDNA or gene expression profile assays.
✕. Pregnant.
✕. Hemodynamically unstable or other serious medical condition that may adversely affect the subject's ability to participate in the study

What they're measuring

Demonstrate the use of Prospera for post-transplant surveillance is non-inferior to the current standard of care, EMB surveillance, with respect to the primary composite endpoint.

Timeframe: 12 months

Trial details

NCT IDNCT05081739

SponsorNatera, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01

View on ClinicalTrials.gov More Heart Transplant Failure and Rejection trials