Recruiting

AI

Sponsor:

Mayo Clinic

Code:

NCT06178744

Conditions

Cardiac Transplant Rejection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this research is to detect episodes of rejection versus non-rejection after cardiac transplant and the diagnostic accuracy of an Artificial Intelligence (AI) algorithm using the data from an ECG (electrocardiogram) and Cardiac Ultrasound (Echocardiogram and/or point of care ultrasound).

Conditions

Cardiac Transplant Rejection

Study ID

NCT06178744

Start date

Apr 4, 2024

Status verified date

Jun, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing post-cardiac transplant endomyocardial biopsy, and the ability to provide informed consent and a consent for the study.

Exclusion Criteria:

  • Refusal of study participation

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Number of episodes identified by the Artificial Intelligence (AI) algorithm as 1R or greater acute cellular rejection, grade 1 or greater antibody mediated rejection, reduction in LVEF to <50%, or a drop in LVEF >5% [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Alyssa Lokensgard

507-422-5123lokensgard.alyssa@mayo.edu

Atta Behfar, MD, PhD

507-266-0318Behfar.Atta@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Ellie Thein

(507) 266-6519Thein.Ellie@mayo.edu

Atta Behfar, MD, PhD

507-266-0318Behfar.Atta@mayo.edu

Principal Investigator:

Atta Behfar, MD, PhD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-24.