Evaluation of Safety and Effectiveness of The SherpaPak in Donation After Circulatory Death Heart Transplantation

NCT05038943 | Completed DMC FDA Device

• 1 other identifier: 0478-21-FB
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Transplant Failure; Determination of Death; Outcomes Research; Extracorporeal Membrane Oxygenation

Keywords

Transplantation, heart; Normothermic Regional Perfusion; Organ transport

Outcome Measures

Primary Outcomes (1)

• Primary Graft Dysfunction (PGD)

  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 MAP \< 70 mm Hg (lasting more than 1 hour) II. One criteria from the following: High-dose inotropes-Inotrope score \>10, or Newly placed IABP (regardless of inotropes)); PGD-LV Grade 3 ( Dependence on left or biventricular mechanical support including ECMO, LVAD, BiVAD, or percutaneous LVAD. Excludes requirement for IABP; PGD-RV (I. Hemodynamics with RAP \> 15 mm Hg, PCWP \< 15 mm Hg, CI \< 2.0 L/min/m2, II. TPG \< 15 mm Hg and/or pulmonary artery systolic pressure \< 50 mm Hg, III. Need for RVAD)

  72 hours

Secondary Outcomes (5)

• Need for cardioversion or pacing to restart transplanted heart

  72 hours

• Vasoactive-inotropic score (VIS)

  24, 48, and 72 hours

• Duration of vasoactive-inotropic support in days

  1 year

• Intensive Care Unit & Hospital length of stay in days

  1 year

• Survival at discharge

  1 year

Study Arms (1)

SherpaPak

EXPERIMENTAL

cardiac allografts recovered from donors after circulatory determined death using thoracoabdominal normothermic regional perfusion will be transported to the recipient center in Paragonix SherpaPak Cardiac Transport System

Device: Paragonix SherpaPak Cardiac Transport System

Interventions

Paragonix SherpaPak Cardiac Transport System DEVICE

Transportation of cardiac allografts in a device maintaining constant optimal temperature to minimize freezing tissue injury

SherpaPak

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recipient is ≥ 19 years old
• Recipient, or their designated healthcare proxy, is able and willing to sign informed consent
• Recipient meets standard listing criteria for heart transplantation

You may not qualify if:

• Recipient is \< 19 years old
• Recipient, or their designated healthcare proxy, is unable to sign informed consent
• 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 Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (4)

• Radakovic D, Karimli S, Penov K, Schade I, Hamouda K, Bening C, Leyh RG, Aleksic I. First clinical experience with the novel cold storage SherpaPak system for donor heart transportation. J Thorac Dis. 2020 Dec;12(12):7227-7235. doi: 10.21037/jtd-20-1827.

  PMID: 33447411 RESULT

• Toldo S, Quader M, Salloum FN, Mezzaroma E, Abbate A. Targeting the Innate Immune Response to Improve Cardiac Graft Recovery after Heart Transplantation: Implications for the Donation after Cardiac Death. Int J Mol Sci. 2016 Jun 17;17(6):958. doi: 10.3390/ijms17060958.

  PMID: 27322252 RESULT

• Kobashigawa J, Zuckermann A, Macdonald P, Leprince P, Esmailian F, Luu M, Mancini D, Patel J, Razi R, Reichenspurner H, Russell S, Segovia J, Smedira N, Stehlik J, Wagner F; Consensus Conference participants. Report from a consensus conference on primary graft dysfunction after cardiac transplantation. J Heart Lung Transplant. 2014 Apr;33(4):327-40. doi: 10.1016/j.healun.2014.02.027. Epub 2014 Mar 5.

  PMID: 24661451 RESULT

• Yamazaki Y, Oba K, Matsui Y, Morimoto Y. Vasoactive-inotropic score as a predictor of morbidity and mortality in adults after cardiac surgery with cardiopulmonary bypass. J Anesth. 2018 Apr;32(2):167-173. doi: 10.1007/s00540-018-2447-2. Epub 2018 Jan 13.

  PMID: 29332153 RESULT

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marian Urban, MD, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cardiac allografts recovered from donors after circulatory death with thoracoabdominal normothermic regional perfusion will be transported with Paragonix SherpaPak Cardiac Transport System to the recipient center

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 9, 2021
• Study Start: September 15, 2021
• Primary Completion: April 8, 2022
• Study Completion: April 8, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)