Clinical trialNCT06895070RecruitingInterventional

XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)

SponsorXVIVO PerfusionEnrollment60Heart FailureHeart TransplantTransplant; Failure, Heart

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Sarah Lowe
XVIVO Perfusion
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

14 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Uc San Diego Health
La Jolla, California, United States
Mark Kearns, M.D.
Recruiting
Cedars Sinai Medical Center
Los Angeles, California, United States
Fardad Esmailian
Recruiting
University of California Los Angeles
Los Angeles, California, United States
Abbas Ardehali, M.D.Reshma Biniwale, M.D.
Recruiting
Stanford University
Stanford, California, United States
Yasuhiro Shudo, PHD, MD
Recruiting
Emory University Hospital
Atlanta, Georgia, United States
Joshua Chan, M.D.Mani Daneshmand, M.D.Victor Pretorius
Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, United States
Benjamin Bryner, M.D.
Recruiting
Washington University - Barnes Jewish Health Hospital
St Louis, Missouri, United States
Amit Pawale, M.D.
Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, United States
Marian Urban, M.D.
Recruiting
Columbia University Medical Center/new York Presbyterian Hospital
New York, New York, United States
Koji Takeda, M.D.
Recruiting
Nyu Langone
New York, New York, United States
Nader Moazami
Recruiting
Duke University Medical Center
Durham, North Carolina, United States
Jacob Schroder, M.D.Jeffrey Keenan, M.D.
Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Ashish S Shah, M.D.
Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Mathias Peltz, M.D.
Recruiting
University of Washington Medical Center
Seattle, Washington, United States
Jay Pal, M.D.
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 10 Jul 2025
Primary completion: 31 May 2026
Completion: 31 May 2031
Last update posted: 18 Mar 2026
Registered enrollment: 60
Registry id: NCT06895070

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.