Menu
Recruiting NCT06895070

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

No phase Interventional Heart Transplant Heart Failure Transplant; Failure, Heart

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT).
Who it may be relevant to
Registry conditions: Heart Transplant, Heart Failure, Transplant; Failure, Heart. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

PRESERVE CAP: A Prospective, Multi-Center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart Preservation From Extended Donors Continued Access Protocol

Overview

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

This is a continuation of the PRESERVE IDE trial to provide additional data evaluating the safety and effectiveness of the XVIVO Heart Assist Transport System. The PRESERVE Continued Access Protocol (CAP) will utilize the XHAT System to preserve donor hearts that may not meet current standard donor heart acceptance criteria with the intention of these hearts being transplanted. The CAP has been implemented to allow patients and physicians access to the XHAT System while a Post-Market Approval (PMA) application is being submitted and reviewed.

Interventions

  • Device Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT)
    Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)

Primary outcome measures

  • The percentage of patient treatment success rate [Time frame: 30 days post transplantation]
  • The percentage of patient survival [Time frame: Post-operative Day 365.]

Eligibility criteria

Inclusion Criteria Recipient:

To be eligible to participate in this study, a recipient must meet all the following criteria:

  • Age ³18 years.
  • Signed informed consent form (ICF).
  • Listed for heart transplantation.

Exclusion Criteria Recipient:

  • Previous solid organ or bone marrow transplantation.
  • Requires a multi-organ transplant.
  • Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted).
  • Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump (IABP).
  • History of complex congenital heart disease ie: single ventricle physiology (per Investigator's discretion and XVIVO review).
  • Subject on renal replacement therapy/dialysis.
  • Ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent).
  • Sensitized participants meeting any of the following:
  • Participant with calculated Panel Reactive Antibody (cPRA) greater than 50%
  • Participant undergoing any desensitization treatment (also with cPRA less than 50%)
  • Participant with a positive prospective crossmatch and/or a positive virtual cross match

Donor Inclusion Criteria:

To be eligible to participate in this study, the donor heart must meet the following criteria:

  • Estimated Cross Clamp Time ≥4 hours OR
  • Estimated Cross Clamp ≥ 2 hours AND

Any one or more of the following:

  • Age ≥50 years
  • LVEF 40% - 50% at time of provisional acceptance. (Refer to section 6.3.4 for definition of provisional acceptance).
  • Down-time ≥20 minutes
  • Hypertrophy septal thickness >12 - ≤16mm
  • Angiographic luminal irregularities with no significant CAD OR 1) Donation after Circulatory Death (DCD)

Donor Exclusion Criteria:

Donor hearts that meet any of the following criteria will be excluded from transplantation in this study:

  • Unstable hemodynamics requiring high-dose inotropic support.
  • Significantly abnormal coronary angiogram defined as CAD > 50% stenosis of one or more vessels or if the donor heart exhibits any contusions, structural damage, gross abnormalities, or palpable CAD on final examination.
  • Moderate to severe cardiac valve pathology.
  • Investigator's clinical decision to exclude from trial.
  • Previous sternotomy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 14 centers
  • UC San Diego Health — La Jolla
  • Cedars Sinai Medical Center — Los Angeles
  • University of California Los Angeles — Los Angeles
  • Stanford University — Stanford
  • Emory University Hospital — Atlanta
  • Northwestern Memorial Hospital — Chicago
  • Washington University - Barnes Jewish Health Hospital — St Louis
  • University of Nebraska Medical Center — Omaha
  • … and 6 more centers

Identifiers

NCT: NCT06895070 · NIHP-CAP-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗