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NCT05038943 · ClinicalTrials.gov registry record · NA
Evaluation of Safety and Effectiveness of The SherpaPak in Donation After Circulatory Death Heart Transplantation
A NA study, sponsored by University of Nebraska.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT05038943: Completed NA study, sponsored by University of Nebraska.
NCT05038943 is a NA study that has completed, run by University of Nebraska. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05038943, a NA study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
This is a prospective, pilot trial to evaluate the safety and effectiveness of The Paragonix SherpaPak™ Cardiac Transport System ("SherpaPak CTS") in transportation of cardiac allografts recovered from donors after circulatory death with thoracoabdominal normothermic regional perfusion (TA-NRP). SherpaPak™ CTS is an ultraportable hypothermic preservation and transport system that has been approved by United States Food \& Drug Administration (FDA) for clinical use in heart transplantation.
Primary Outcome
PGD will be classified according to International Society for Heart and Lung Transplantation (ISHLT) classification into: PGD-LV Grade 1 (LVEF ≤ 40% by echocardiography, or Hemodynamics with RAP \> 15 mm Hg, PCWP \> 20 mm Hg, CI \< 2.0 L/min/m2 (lasting more than 1 hour) requiring low-dose inotropes); PGD-LV Grade 2 (I. One criteria from the following: Left ventricular ejection fraction ≤ 40%, or Hemodynamic compromise with RAP \> 15 mm Hg, PCWP \> 20 mm Hg, CI \< 2.0 L/min/m2, hypotension with
Interventions
- DEVICE Paragonix SherpaPak Cardiac Transport System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-09-15 |
| Est. Completion | 2022-04-08 |
| Phase | NA |
What the finished NCT05038943 record still lists
NCT05038943 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Paragonix SherpaPak Cardiac Transport System is the first listed.
NCT05038943 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05038943 about?
NCT05038943 is a clinical study titled "Evaluation of Safety and Effectiveness of The SherpaPak in Donation After Circulatory Death Heart Transplantation". This is a prospective, pilot trial to evaluate the safety and effectiveness of The Paragonix SherpaPak™ Cardiac Transport System ("SherpaPak CTS") in transportation of cardiac allografts recovered from donors after circulatory death with thoracoabdominal normothermic regional perfusion (TA-NRP). She...
What is the current status of trial NCT05038943?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2021-09-15. Estimated completion is 2022-04-08.
What interventions are being tested in trial NCT05038943?
The interventions under investigation include: Paragonix SherpaPak Cardiac Transport System (DEVICE).
Who is sponsoring clinical trial NCT05038943?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05038943's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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