NCT05205551

Prospera Test Evaluation in Cardiac Transplant (ProTECT)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 411 (actual)
• Sponsor: Natera, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera testing is part of routine clinical care, who are enrolled within 60 days of heart transplantation.

Detailed description

The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera™ testing is part of routine clinical care, who are enrolled within 60 days of heart transplantation. Patients who are enrolled in this study should have blood drawn for Prospera™ testing at regular intervals per routine clinical care. Prospera™ test results and results of surveillance endomyocardial biopsies, laboratory testing, echocardiograms, angiography and hemodynamic monitoring performed to monitor cardiac status and for signs of transplant rejection, as well as medications and post-transplant re-vascularization and surgical procedures will be recorded in the electronic case report form (eCRF). Patient management decisions, even those informed by the Prospera™ test result, are made based on the individual judgment of the healthcare providers participating in the study.

Conditions

• Heart Transplant Rejection

Timeline

• Start date: 2021-10-01
• Primary completion: 2026-10-31
• Completion: 2027-06-30
• First posted: 2022-01-25
• Last updated: 2025-05-22

Locations

1 site across 1 country: United States