Direct Procurement (DP) and Hypothermic Oxygenated Perfusion (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of the clinical investigation is to support the use of direct procurement of donor hearts in donation after circulatory death followed by hypothermic oxygenated perfusion using the XVIVO Heart Assist Transport System. Thereby increasing the utilization of DCD donor hearts in donation after circulatory death. The primary objective is to evaluate patient survival after direct procurement and hypothermic oxygenated machine perfusion of DCD donor hearts using the XVIVO Heart Assist Transport System. The secondary objectives are to evaluate patient outcomes and graft function post-transplant.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years

• Signed informed consent form

• Accepted and/or listed for heart transplantation

Locations
Other Locations
Belgium
UZ Leuven
RECRUITING
Leuven
Contact Information
Primary
Marina Fredholm, MSc
marina.fredholm@xvivogroup.com
+46 733 929 502
Backup
Sofia Jonhede, MSc
sjonhede@gmail.com
+46 763 286 731
Time Frame
Start Date: 2024-08-03
Estimated Completion Date: 2026-06
Participants
Target number of participants: 20
Treatments
Experimental: DCD Direct procurement
Direct procurement of DCD donor hearts
Related Therapeutic Areas
Sponsors
Leads: XVIVO Perfusion

This content was sourced from clinicaltrials.gov