Surveillance HeartCare® Outcomes Registry
(SHORE Trial)

Recruiting in Palo Alto (17 mi)

+79 other locations

Overseen ByJeffrey Teuteberg

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: CareDx

No Placebo Group

Approved in 1 jurisdiction

Trial Summary

What is the purpose of this trial?This is an observational registry to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.

Eligibility Criteria

Participant Groups

2Treatment groups

Experimental Treatment

Group I: HeartCareExperimental Treatment1 Intervention

Diagnostic Test: Heart Care 2300 patients managed with HeartCare (AlloMap® and AlloSure-Heart® )

Group II: ControlExperimental Treatment1 Intervention

A historical control group will be matched to the estimated 1150 HeartCare group patients who complete at least two years of HeartCare surveillance use and inclusive of year 3 post-transplant clinical follow-up for outcome. The criteria for the matched controls will be based on allograft donor type, age, gender, ethnicity/race, and other clinical factors. Propensity scores will be used to perform the matching.