Heart Transplantation Using Normothermic Regional Perfusion Donation After Circulatory Death
1 other identifier
interventional
10
1 country
1
Brief Summary
Normothermic regional perfusion (NRP) utilizes Extracorporeal Membrane Oxygenation (ECMO) or cardiopulmonary bypass to reperfuse the heart and other organs in situ after isolation and ligation of the cerebral vessels. In situ resuscitation of the heart has the added advantage of allowing full hemodynamic and echocardiographic assessment of the donor heart prior to final acceptance for transplantation without the imminent danger of ongoing warm ischemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Jan 2020
Typical duration for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2020
CompletedFirst Submitted
Initial submission to the registry
January 24, 2020
CompletedFirst Posted
Study publicly available on registry
February 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedFebruary 13, 2023
February 1, 2023
2.9 years
January 24, 2020
February 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Successful NRP-DCD Heart transplants
The primary outcome is the rate of successful NRP-DCD heart transplants.
One Year
Secondary Outcomes (4)
Number of living authorized representatives who authorize candidate's organs for donation and research
One Year
Number of candidates who are transferred to NYU Langone Health for donation after circulatory death (DCD)
One Year
Number of candidates who progress to death after withdrawal of care
One Year
Number of Donors whose hearts are deemed suitable for donation following normothermic regional perfusion (NRP)
One Year
Study Arms (1)
DCD Heart Transplantation Using NRP
EXPERIMENTALHeart Transplantation Using Normothermic Regional Perfusion (NRP) Donation After Circulatory Death (DCD)
Interventions
Heart Transplantation Using Normothermic Regional Perfusion (NRP) Donation After Circulatory Death (DCD)
Eligibility Criteria
You may qualify if:
- Recipient is ≥ 18 years old
- Recipient, or their designated healthcare proxy, is able and willing to sign informed consent
- Recipient meets standard listing criteria for heart transplantation at NYU Langone Health Transplant Institute
You may not qualify if:
- Recipient is \< 18 years old
- Recipient, or their designated healthcare proxy, is unable to sign informed consent
- Recipient is participating in another interventional trial
- Recipient has a known history of HIV infection
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nader Moazami, MD
NYU Langone
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2020
First Posted
February 25, 2020
Study Start
January 20, 2020
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
February 13, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share