Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-02 @ 1:09 AM
Study NCT ID:
NCT05205551
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-22
First Post:
2022-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospera Test Evaluation in Cardiac Transplant (ProTECT)
Sponsor:
Natera, Inc.
Organization:
Study Overview
Official Title:
Prospera Test Evaluation in Cardiac Transplant (ProTECT)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProTECT
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: