PRESERVE CAP: A Prospective, Multi-Center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart Preservation From Extended Donors Continued Access Protocol
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ To be eligible to participate in this study, a recipient must meet all the following criteria:
• Age ³18 years.
• Signed informed consent form (ICF).
• Listed for heart transplantation.
Locations
United States
California
Cedars Sinai Medical Center
RECRUITING
Los Angeles
University of California Los Angeles
RECRUITING
Los Angeles
Georgia
Emory University Hospital
RECRUITING
Atlanta
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
North Carolina
Duke University Medical Center
RECRUITING
Durham
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
New York
Columbia University Medical Center/New York Presbyterian Hospital
NOT_YET_RECRUITING
New York
NYU Langone
RECRUITING
New York
Tennessee
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Contact Information
Primary
Amanda Carpenter
Amanda.Carpenter@xvivogroup.com
617-283-8332
Backup
Jen Ruel
jen.ruel@xvivogroup.com
Time Frame
Start Date: 2025-07-10
Estimated Completion Date: 2031-05
Participants
Target number of participants: 60
Treatments
Experimental: Device: Preservation of hearts for transplant.
Device: Preservation of hearts for transplant.
Related Therapeutic Areas
Sponsors
Leads: XVIVO Perfusion