XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)
Part of paid clinical trials in La Jolla, California.
- Sponsor
- XVIVO Perfusion
- Study ID
- NCT06895070
- Status
- Recruiting
Conditions
- Heart Failure
- Heart Transplant
- Transplant; Failure, Heart
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT) — DEVICEStudy donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
Study Details
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.
Key Dates
- Start date
- Jul 10, 2025
- Status verified
- Feb 2026
- Primary completion
- May 31, 2026
- Completion
- May 31, 2031
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Device: Preservation of hearts for transplant.Device: Preservation of hearts for transplant.
Primary Outcome Measure
The percentage of patient treatment success rate [ Time Frame: 30 days post transplantation ]
Central Contacts
- Amanda Carpenter617-283-8332
- Jen Ruel
Locations (14)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UC San Diego Health | La Jolla | California | 92037 | Mark Kearns, M.D. (PRINCIPAL_INVESTIGATOR) |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | Fardad Esmailian (PRINCIPAL_INVESTIGATOR) |
| University of California Los Angeles | Los Angeles | California | 90095-1405 | Steven Stokes Abbas Ardehali, M.D. (PRINCIPAL_INVESTIGATOR) Reshma Biniwale, M.D. (SUB_INVESTIGATOR) |
| Stanford University | Stanford | California | 94305 | Yasuhiro Shudo, PHD, MD (PRINCIPAL_INVESTIGATOR) |
| Emory University Hospital | Atlanta | Georgia | 30322 | Mani Daneshmand, M.D. (PRINCIPAL_INVESTIGATOR) Joshua Chan, M.D. (SUB_INVESTIGATOR) Victor Pretorius (SUB_INVESTIGATOR) |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611-5969 | Benjamin Bryner, M.D. (PRINCIPAL_INVESTIGATOR) |
| Washington University - Barnes Jewish Health Hospital | St Louis | Missouri | 63110 | Amit Pawale, M.D. (PRINCIPAL_INVESTIGATOR) |
| University of Nebraska Medical Center | Omaha | Nebraska | 69198-2265 | Marian Urban, M.D. (PRINCIPAL_INVESTIGATOR) |
| Columbia University Medical Center/New York Presbyterian Hospital | New York | New York | 10032 | Koji Takeda, M.D. (PRINCIPAL_INVESTIGATOR) |
| NYU Langone | New York | New York | 10016 | Jacquline Bott Nader Moazami (PRINCIPAL_INVESTIGATOR) |
| Duke University Medical Center | Durham | North Carolina | 27710 | Mary Motta Jacob Schroder, M.D. (PRINCIPAL_INVESTIGATOR) Jeffrey Keenan, M.D. (SUB_INVESTIGATOR) |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Ashish S Shah, M.D. (PRINCIPAL_INVESTIGATOR) |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | Mathias Peltz, M.D. (PRINCIPAL_INVESTIGATOR) |
| University of Washington Medical Center | Seattle | Washington | 98195 | Jay Pal, M.D. (PRINCIPAL_INVESTIGATOR) |
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