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Development of Non-invasive Cell-free DNA to Supplant Invasive Biopsy in Heart Transplantation

NCT05309382 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 147

Last updated 2024-10-29

No results posted yet for this study

Summary

This is a prospective, multicenter observational, unblinded, longitudinal cohort study. Subjects will be enrolled into the study prior to or at the time of heart transplantation. All subjects will follow the center's standard of care surveillance schedule. Blood samples will be collected for Prospera testing at the time any surveillance or for-cause testing, which may include endomyocardial biopsy (EMB), echocardiography or other cardiac imaging studies, and/or molecular testing, is performed.

Conditions

  • Heart Transplant

Interventions

DIAGNOSTIC_TEST

Prospera

Monthly testing and results provided

Sponsors & Collaborators

  • Natera, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Olymbios, MD · Natera, Inc.

  • Palak Shah, MD · Inova Health Care Services

  • Josef Stehlik, MD · University of Utah

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2024-10-02
Completion
2024-10-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05309382 on ClinicalTrials.gov