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

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ClinicalTrials.gov Identifier: NCT05881278
Recruitment Status : Recruiting
First Posted : May 31, 2023
Last Update Posted : February 26, 2024
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heart Failure Transplant; Failure, Heart Device: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS) Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 141 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 10, 2023
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : March 2030

Arm Intervention/treatment
Experimental: Subjects requiring a Heart Transplant
Device: Preservation of hearts for transplant.
Device: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)




Primary Outcome Measures :
  1. The percentage of patient survival [ Time Frame: 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.

  2. The percentage of patient treatment success rate [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05881278


Contacts
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Contact: Sarah Lowe 303-881-7700 sarah.lowe@xvivogroup.com

Locations
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United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Connor Davies    858-246-0872    crdavies@health.ucsd.edu   
Principal Investigator: Victor Pretorius, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Allison Mossell       allison.mossell@nm.org   
Principal Investigator: Benjamin Bryner, MD         
United States, New York
Columbia University Irving Medical Center/New York Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Contact: Amanda Alonso, MHA, CCRC    212-342-0261    aa2974@cumc.columbia.edu   
Principal Investigator: Koji Takeda, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Susan Hajmohammad, BS    919-684-1988    susan.hajmohammad@duke.edu   
Contact: Sarah Casalinova, BS    919-613-5621    sarah.casalinova@duke.edu   
Principal Investigator: Jacob Schroder, MD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Lisa Slinger    615-875-2602    lisa.slinger@vumc.org   
Principal Investigator: Ashish Shah, MD         
Sponsors and Collaborators
XVIVO Perfusion
Investigators
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Study Director: Jaya Tiwari XVIVO Perfusion
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Responsible Party: XVIVO Perfusion
ClinicalTrials.gov Identifier: NCT05881278    
Other Study ID Numbers: NIHP - 001
First Posted: May 31, 2023    Key Record Dates
Last Update Posted: February 26, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases