Clinical Trial

XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)

Study acronym: NIHP-CAP-001
Recruiting
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Record status
This record was last updated March 18, 2026 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
Summary
The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2025-03-18; most recent amendment 2026-03-16.
Status change: Not Yet Recruiting → Recruiting 2025-07-10
Trial Details
NCT Number NCT06895070
Lead Sponsor XVIVO Perfusion
Conditions Heart Transplant, Heart Failure, Transplant; Failure, Heart
Enrollment 60 participants
Start Date 2025-07-10
Primary Completion 2026-05 (estimated)
Study Completion 2031-05 (estimated)
Updated on ClinicalTrials.gov 2026-03-18