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NCT06414603 · ClinicalTrials.gov registry record · NA

A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy

A NA study of Heart Transplant Failure and Rejection, sponsored by Natera.

Active
Registry status
NA
Development phase
250
Enrollment target
16
Study locations

NCT06414603 is a NA study of Heart Transplant Failure and Rejection that is active but no longer recruiting, run by Natera. The registered enrollment target is 250 participants, above the 161-participant average among 5 other Heart Transplant Failure and Rejection trials with a reported enrollment target (55% higher). The trial reports 16 study locations across 13 states.

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The verdict

NCT06414603, a NA study of Heart Transplant Failure and Rejection, is active but no longer recruiting, sponsored by Natera.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
250 participants
Enrollment target
16
Study locations

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

Heart Transplant Failure and Rejection

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

FieldValue
Enrollment Target 250 participants
Start Date 2024-06-10
Est. Completion 2027-02
Phase NA

Sponsor

Natera

27 total trials

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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, categorized as NA. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 161-participant average among 5 other Heart Transplant Failure and Rejection trials with a reported enrollment target (55% higher). The listed sponsor is Natera, which has 27 total studies on file at ClinicalTrials.gov.

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.

NCT06414603 reports 16 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Texas.

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.

What interventions are being tested in trial NCT06414603?

The interventions under investigation include: The Prospera™ Test (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT06414603?

This trial is sponsored by Natera, which has 27 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.