RECRUITING

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

Conditions

Heart Transplant Heart Failure Transplant; Failure, Heart

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2025-07-10

Study Completion:2031-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06895070

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Amanda Carpenter

CONTACT

617-283-8332

Amanda.Carpenter@xvivogroup.com

Jen Ruel

CONTACT

jen.ruel@xvivogroup.com

Principal Investigator

Sarah Lowe

STUDY_DIRECTOR

XVIVO Perfusion

Study Locations (Sites)

University of Nebraska Medical Center

Omaha, Nebraska, 69198-2265

United States

Collaborators and Investigators

Sponsor: XVIVO Perfusion

Sarah Lowe, STUDY_DIRECTOR, XVIVO Perfusion

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-10

Study Completion Date2031-05

Study Record Updates

Study Start Date2025-07-10

Study Completion Date2031-05

Terms related to this study

Additional Relevant MeSH Terms

Heart Transplant
Heart Failure
Transplant; Failure, Heart