141 Participants Needed

XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)

Recruiting at 21 trial locations
SL
Overseen BySarah Lowe
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: XVIVO Perfusion
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

JT

Jaya Tiwari

Principal Investigator

XVIVO Perfusion

Eligibility Criteria

Inclusion Criteria

Signed informed consent form (ICF).
You have been registered for a heart transplant.
You are the recipient.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Preservation of hearts for transplant using the XVIVO Heart Preservation System (XHPS)

Immediate pre-transplant period

Follow-up

Participants are monitored for safety and effectiveness after treatment

365 days

Treatment Details

Participant Groups
1Treatment groups
Experimental Treatment
Group I: Subjects requiring a Heart TransplantExperimental Treatment1 Intervention
Device: Preservation of hearts for transplant.

Find a Clinic Near You

Who Is Running the Clinical Trial?

XVIVO Perfusion

Lead Sponsor

Trials
11
Recruited
1,200+
Unbiased ResultsWe believe in providing patients with all the options.
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