Global Utilization And Registry Database for Improved heArt preservatioN

Enrolling by invitationOBSERVATIONAL
Enrollment

3,000

Participants

Timeline

Start Date

February 14, 2020

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2029

Conditions
Heart DiseasesHeart FailureHeart Defects, Congenital
Interventions
DEVICE

SherpaPak Cardiac Transport System

"The Paragonix SherpaPak Cardiac Transport System (SherpaPak CTS) is an ultraportable hypothermic preservation and transport system intended for use with donor hearts. The device is a legally marketed, FDA cleared medical device in the United States and CE Marked medical device in the European Union.~The SherpaPak CTS consists of multiple components: 1) outer transport shipper which contains within various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell assembly which provides a rigid barrier enclosure in which the heart is immersed and suspended in a cold storage solution cleared for use in storing and transporting donor hearts, 3) a data logger that monitors and displays the temperature of the cold storage solution in which the heart is stored during transport, and 4) four size heart connectors designed to accommodate various size aortic stem diameters by which donor hearts are attached."

Trial Locations (22)

1090

Allgemeines Krankenhaus Wien, Vienna

8036

University of Graz, Graz

10032

NewYork-Presbyterian Columbia University Irving Medical Center, New York

16801

Pennslyvania State University, State College

20010

Medstar Washington Hospital, Washington D.C.

23507

Sentara Healthcare, Norfolk

27708

Duke University, Durham

32224

Mayo Clinic, Jacksonville

32608

University of Florida Health Shands Hospital, Gainesville

32803

AdventHealth Orlando, Orlando

38103

Le Bonheur Children's Hospital, Memphis

45229

Cincinnati Children's Hospital, Cincinnati

46804

Lutheran Hospital, Fort Wayne

49503

Spectrum Health, Grand Rapids

66045

Kansas University Medical Center, Lawrence

75246

Baylor University Medical Center, Dallas

94305

Stanford University, Stanford

02111

Tufts University Medical Center, Boston

02114

Massachusetts General Hospital, Boston

Unknown

Hospital Universitario 12 de Octubre, Madrid

Hospital Clínico Universitario de Valladolid, Valladolid

Manchester University, Manchester

Sponsors
All Listed Sponsors
lead

Paragonix Technologies

INDUSTRY