MedPath

Surveillance HeartCare® Outcomes Registry

Active, not recruiting
Conditions
Heart Transplant Rejection
Registration Number
NCT03695601
Lead Sponsor
CareDx
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
All
Target Recruitment
2743
Inclusion Criteria

Inclusion Criteria:<br><br> 1. Patients who are 15 years of age or older at the time of blood draw.<br><br> 2. Received a heart transplant (primary or repeat)<br><br> 3. Patients who have HeartCare initiated within 3 months post-transplant<br><br>Exclusion Criteria:<br><br> 1. Patients who are pregnant at the time of blood draw.

Exclusion Criteria

Not provided

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Proportion of patients who develop de-novo DSA as a surrogate to clinical outcomes at 1, 3 and 5 years post-transplant.
Secondary Outcome Measures
NameTimeMethod
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