XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)
NCT05881278 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 141
Last updated 2026-04-01
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.
Conditions
- Heart Failure
- Transplant; Failure, Heart
Interventions
- DEVICE
-
Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
Sponsors & Collaborators
-
XVIVO Perfusion
lead INDUSTRY
Principal Investigators
-
Jaya Tiwari · XVIVO Perfusion
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-10
- Primary Completion
- 2025-11-22
- Completion
- 2029-11-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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