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A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy
NCT06414603 · View on ClinicalTrials.gov ↗
Study Summary
This is an open label Comparative Effectiveness Research (CER) study in which patients will be randomized at the site level to Prospera surveillance or EMB surveillance in a 2:1 ratio (Prospera to EMB) at each site. Subjects will be enrolled into the study while under evaluation for heart transplantation or on the transplant waiting list prior to heart transplantation. All subjects will follow the center's standard of care surveillance schedule from transplant through 4 weeks post-transplantation. EMB during this phase is expected to occur roughly weekly or bi-weekly. Study group assignment will take place at randomization. Subjects will be randomized 30 days (± 10 days) post-transplant to Prospera surveillance versus EMB surveillance in a 2:1 ratio. Rejection surveillance (Prospera Group and EMB Group) will be performed at times corresponding to the institutional standard of care schedule for rejection surveillance.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST The Prospera™ Test
Study Locations (16)
California
- Cedars-Sinai Medical Center — Los Angeles
- University of California, San Diego — San Diego
Florida
- Mayo Clinic — Jacksonville
- AdventHealth Orlando — Orlando
Texas
- University of Texas, Southwestern Medical Center — Dallas
- Baylor Scott White - Temple — Temple
Colorado
- University of Colorado — Aurora
Kansas
- Kansas University Medical Center — Kansas City
Massachusetts
- Brigham and Women's Hospital — Boston
Michigan
- University of Michigan — Ann Arbor
New York
- NYU Langone Health — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2024-06-10 |
| Est. Completion | 2027-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06414603
The ClinicalTrials.gov registry entry for NCT06414603 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Natera, which has 40 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Heart Transplant Failure and Rejection appearing as the primary indexed condition, and to 1 intervention — of which The Prospera™ Test is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06414603 reports 16 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06414603 about?
NCT06414603 is a clinical study titled "A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy". This is an open label Comparative Effectiveness Research (CER) study in which patients will be randomized at the site level to Prospera surveillance or EMB surveillance in a 2:1 ratio (Prospera to EMB) at each site. Subjects will be enrolled into the study while under evaluation for heart transplan...
What is the current status of trial NCT06414603?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2024-06-10. Estimated completion is 2027-02.
What conditions does trial NCT06414603 study?
This clinical trial studies the following conditions: Heart Transplant Failure and Rejection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06414603?
The interventions under investigation include: The Prospera™ Test (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06414603?
This trial is sponsored by Natera, which has 40 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06414603 being conducted?
This trial has 16 study locations across California, Colorado, Florida, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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