Ignite Creation Date:
2024-07-17 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485596
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-25
Brief Title:
HOPE at Heart HOPE of Donor Hearts After Circulatory Death DCD Using the XVIVO Heart Assist Transport System
Sponsor:
XVIVO Perfusion
Organization:
XVIVO Perfusion
Study Overview
Official Title:
Direct Procurement DP and Hypothermic Oxygenated Perfusion HOPE of Donor Hearts After Circulatory Death DCD Using the XVIVO Heart Assist Transport System
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOPEHeart
Brief 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
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
Detailed Description:
This is a prospective single-arm multi-national multicentre proof-of-concept study to evaluate post-transplant outcomes after the use of direct procurement followed by a period of hypothermic oxygenated perfusion of the donor heart in DCD using the XVIVO Heart Assist Transport system
The investigation will be conducted at 4 heart transplant centres one in Belgium and three in The NetherlandsThe study will include 20 DCD heart transplant recipients and will evaluate transplant outcomes such as post-transplant complications patient survival and graft function for a period of 6 months post-transplant
The study will not include a control group as this is a proof-of-concept study investigating an alternative method of procurement of DCD hearts by providing additional safety and performance data
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
The investigation will be conducted at 4 heart transplant centres one in Belgium and three in The NetherlandsThe study will include 20 DCD heart transplant recipients and will evaluate transplant outcomes such as post-transplant complications patient survival and graft function for a period of 6 months post-transplant
The study will not include a control group as this is a proof-of-concept study investigating an alternative method of procurement of DCD hearts by providing additional safety and performance data
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None