Heart Transplantation Utilizing NRP DCD

NCT05243914 | Terminated

• 1 other identifier: STUDY00000230
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, observational, pilot trial to evaluate the feasibility of heart transplantation using normothermic regional perfusion (NRP) donation after donor circulatory death (DCD). Adults who meet standard criteria for heart transplantation listing and study-specific eligibility criteria will enroll in the study. the investigators anticipate evaluating an initial cohort of approximately 100 DCD donors for a final yield of 40 hearts. The investigators will accept donors between the ages of 18 and 65 who are determined to have heart function/quality appropriate for donation for transplantation based on available donor data and testing. If feasible, donors might be relocated to BUMCP to maintain uniformity of process, minimize cold ischemic time, and allow for more rapid and improved communication during the initial pilot phase. Recipients will be selected based on blood group, crossmatch, size match, and clinical stability per standard allocation practices. Recipients will be followed post-transplantation per BUMCP Heart Transplant standard protocol.

Conditions

Heart Transplantation; Perfusion; Transplant Recipients

Keywords

Normothermic Regional Perfusion (NRP); Donation After Circulatory Death (DCD); Heart Transplantation; Observational Study

Outcome Measures

Primary Outcomes (1)

• Evaluation of feasibility

  To evaluate the survival of heart transplantation recipients using normothermic regional perfusion (NRP) donation after circulatory death (DCD).

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Evaluation of Incidence of Rejection

  through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We anticipate evaluating an initial cohort of approximately 100 DCD donors for a final yield of 40 hearts suitable for transplantation. Donors will be between the ages of 18 and 65 who are determined to have heart function/quality that is appropriate for donation for transplantation based on available donor data and testing. Donors might be transported to BUMCP with the intent of implanting the recipients at BUMCP. It is preferable to relocate the donor and recipient to maintain uniformity of process, minimize cold ischemic time and allow for rapid and improved communication during the initial pilot phase.

You may qualify if:

• Recipient is ≥ 18 years old
• Recipient, or their designated healthcare proxy, is able and willing to sign an informed consent
• The recipient meets standard listing criteria for heart transplantation.

You may not qualify if:

• Recipient is \< 18 years old
• Recipient, or their designated healthcare proxy, is unable to sign an informed consent
• The recipient is participating in another interventional trial
• The recipient has a known history of HIV infection
• The recipient has any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Internal Medicine

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 17, 2022
• Study Start: January 21, 2022
• Primary Completion: July 4, 2023
• Study Completion: January 3, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)