ACES-EMB

What is the Purpose of this Study?

To compare the effectiveness of rejection surveillance of heart transplant recipients with Prospera dd-cfDNA to rejection surveillance with endomyocardial biopsy (EMB) and histology in the first post-transplant year. To compare the rates of biopsy-associated complications between subjects managed with Prospera dd-cfDNA and subjects managed with surveillance EMB To compare the quality-of-life between heart transplant recipients managed with Prospera dd-cfDNA compared with surveillance EMB To describe miRNA expression in stable heart transplant recipients and changes in miRNA expression during episodes of AR and heart allograft dysfunction.


Eligibility

  • 1. Age 18 years or older at the time of signing informed consent.
  • 2. Undergoing transplant evaluation or currently on the heart transplant waiting list and expected to receive a heart transplant.
  • 3. Able to read, understand and provide written informed consent. If the patient is unable to sign informed consent, a legally authorized representative (LAR) can consent on behalf of the patient.
  • 4. Able and willing to comply with the study visit schedule, study procedures and study requirements.
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

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

Study Details
Disease Type/Condition

Other

Principal Investigator

Ghafourian, Kambiz

Age Group

Adult

Phase

N/A

IRB Number

STUDY00003510

ClinicalTrials.gov ID

NCT06414603

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Ghafourian, Kambiz

Age Group

Adult

Phase

N/A

IRB Number

23-069-TRP

ClinicalTrials.gov ID

NCT06414603

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org