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

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

January 31, 2023

Primary Completion Date

January 31, 2025

Study Completion Date

January 31, 2026

Conditions
Heart Transplant Failure and Rejection
Interventions
DIAGNOSTIC_TEST

Prospera Transplant Assessment

"Prospera™ detects allograft rejection noninvasively and with high accuracy by measuring the fraction of dd-cfDNA in the patient's blood, without the need for prior donor or recipient genotyping.~Prospera is a commercially available LDT developed by Natera, Inc. Natera is a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA)."

PROCEDURE

Endomyocardial biopsy

Subjects will undergo surveillance EMB per the institution's standard clinical care, which is expected to be approximately every other week in months 2 and 3, then monthly through month 6, then every 1-3 months through the end of month 12.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Natera, Inc.

INDUSTRY

NCT05081739 - Donor-Derived Cell-free DNA to DETect REjection in Cardiac Transplantation | Biotech Hunter | Biotech Hunter