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

Not Applicable

Active, not recruiting

• Conditions: Transplant; Failure, Heart; Heart Failure
• Interventions: Device: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)

• Registration Number: NCT05881278
• Lead Sponsor: XVIVO Perfusion

Brief 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.

Detailed Description

PRESERVE Heart Study - This is a prospective, multicenter, non-randomized, single arm, open label study in subjects requiring a Heart Transplant. Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS).

Study Timeline

• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-05-18
• Study First Posted: 2023-05-31
• Study Start: 2023-10-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Primary Completion: 2025-11
• Study Completion: 2029-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

1. Age ≥18 years.
2. Signed informed consent form (ICF).
3. Listed for heart transplantation

Recipient

Exclusion Criteria

1. Previous solid organ or bone marrow transplantation.
2. Requires a multi-organ transplant.
3. Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted).
4. Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump.
5. History of complex congenital heart disease ie: single ventricle physiology (Per Investigators discretion).
6. Subject on renal replacement therapy/dialysis.
7. Ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent).
8. Sensitized subject is undergoing desensitization treatment.

Donor Inclusion Criteria:

1. Estimated Cross Clamp Time ≥ 4 hours, OR

2. Estimated Cross Clamp Time ≥ 2 hours, AND

   Any ONE or more of the following:

   • Age ≥ 50 years
   • LVEF 40-50% at time of provisional acceptance
   • Down-time ≥ 20 mins
   • Hypertrophy/Septal thickness >12- ≤16mm
   • Angiographic luminal irregularities with no significant CAD, OR

3. Donation after Circulatory Death (DCD) donors.

Donor Exclusion Criteria:

1. Unstable hemodynamics requiring high-dose inotropic support.
2. Significantly abnormal coronary angiogram defined as CAD > 50% stenosis of one or more vessels.
3. Moderate to severe cardiac valve pathology.
4. Investigator's clinical decision to exclude from trial.
5. Previous Sternotomy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects requiring a Heart Transplant	Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)	Device: Preservation of hearts for transplant.

Primary Outcome Measures

Name	Time	Method
The percentage of patient treatment success rate	30 days post transplantation	The percentage of patient treatment success rate at 30-days post transplantation. The treatment success is defined as freedom from treatment failure.
The percentage of patient survival	Post-operative Day 365.	The percentage of patient survival at 365 days from the date of transplant. The long-term safety success is defined as survival.

Trial Locations

Locations (20)

University of California San Diego; 🇺🇸 La Jolla, California, United States

Cedars-Sinai; 🇺🇸 Los Angeles, California, United States

David Geffen School of Medicine at UCLA; 🇺🇸 Los Angeles, California, United States

Stanford Medicine; 🇺🇸 Palo Alto, California, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

University of Maryland Medical Center/University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Medicine; 🇺🇸 Baltimore, Maryland, United States

Washington University - Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

Columbia University Irving Medical Center/New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States