NCT05881278

XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)

PRESERVE Heart Study: A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart PRESERVation From Extended Donors

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 141 (estimated)
• Sponsor: XVIVO Perfusion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRESERVE Heart Study - This is a prospective, multicenter, non-randomized, single arm, open label study in subjects requiring a Heart Transplant. Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS).

Conditions

• Heart Failure
• Transplant; Failure, Heart

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2023-10-10
• Primary completion: 2025-11-22
• Completion: 2029-11-01
• First posted: 2023-05-31
• Last updated: 2026-04-01

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated device study