RECRUITING

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

Description

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.

Conditions

Heart TransplantHeart FailureTransplant; Failure, Heart
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Related Conditions:

Heart TransplantHeart FailureTransplant; Failure, Heart

Study Overview

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Study Details

Study 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.

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

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

Condition
Heart Transplant
Intervention / Treatment

-

Contacts and Locations

Omaha

University of Nebraska Medical Center, Omaha, Nebraska, United States, 69198-2265

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Estimated Cross Clamp Time ≥4 hours OR
  • 2. Estimated Cross Clamp ≥ 2 hours AND
  • * 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)
  • 1. Unstable hemodynamics requiring high-dose inotropic support.
  • 2. 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.
  • 3. Moderate to severe cardiac valve pathology.
  • 4. Investigator's clinical decision to exclude from trial.
  • 5. Previous sternotomy.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

XVIVO Perfusion,

Sarah Lowe, STUDY_DIRECTOR, XVIVO Perfusion

Study Record Dates

2031-05