Clinical trial NCT05881278: XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)
Official title: PRESERVE Heart Study: A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart PRESERVation From Extended Donors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Transplant; Failure, Heart
Lead sponsor: XVIVO Perfusion
Sponsor class: INDUSTRY
First posted: 2023-05-31
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: Recipient 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.

Primary outcomes:
measure: The percentage of patient survival
timeFrame: Post-operative Day 365.
measure: The percentage of patient treatment success rate
timeFrame: 30 days post transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
city: Palo Alto
country: United States
facility: Stanford Medicine
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland Medical Center/University of Maryland, Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
city: Saint Louis
country: United States
facility: Washington University - Barnes Jewish Hospital
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center/New York Presbyterian Hospital
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: XVIVO Perfusion
name: Jaya Tiwari
role: STUDY_DIRECTOR
References: