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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoints: | Primary molecular endpoint: percent of donor-derived cell-free DNA (dd-cfDNA) measured via the Prospera™ test. Primary clinical endpoints:
| 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoints | The secondary endpoints are:
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Patients must meet all the following criteria to be eligible for the study:
Patients are not eligible for the study if they meet any of the following criteria:
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Heart Transplantation Patients
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| Name | Affiliation | Role |
|---|---|---|
| Michael Olymbios, MD | Natera, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Natera | San Carlos | California | 94070 | United States |
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| 3 years |