Global Utilization And Registry Database for Improved heArt preservatioN

Part of paid clinical trials in Stanford, California.

Sponsor
Paragonix Technologies
Study ID
NCT04141605
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • SherpaPak Cardiac Transport System — DEVICE
    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.

Study Details

The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving heart transplants using donor hearts transported via the SherpaPak CTS System. These results will be compared to outcomes of retrospective patients whose hearts were transported with the previous standard method.

Key Dates

Start date
Feb 14, 2020
Status verified
May 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
3,000 participants (estimated)

Arms

  • Arm: SherpaPak CTS Patients
    Patients whose donor heart was transported with the SherpaPak CTS
  • Arm: Standard Transport Patients
    Patients whose donor heart was transported with a method other than SherpaPak CTS in the past two years

Primary Outcome Measure

Number of Patients with Primary Graft Dysfunction [ Time Frame: one year ]

Locations (17)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-
Medstar Washington HospitalWashington D.C.District of Columbia20010-
University of Florida Health Shands HospitalGainesvilleFlorida32608-
Mayo ClinicJacksonvilleFlorida32224-
AdventHealth OrlandoOrlandoFlorida32803-
Lutheran HospitalFort WayneIndiana46804-
Kansas University Medical CenterLawrenceKansas66045-
Massachusetts General HospitalBostonMassachusetts02114-
Tufts University Medical CenterBostonMassachusetts02111-
Spectrum HealthGrand RapidsMichigan49503-
NewYork-Presbyterian Columbia University Irving Medical CenterNew YorkNew York10032-
Duke UniversityDurhamNorth Carolina27708-
Cincinnati Children's HospitalCincinnatiOhio45229-
Pennslyvania State UniversityState CollegePennsylvania16801-
Le Bonheur Children's HospitalMemphisTennessee38103-
Baylor University Medical CenterDallasTexas75246-
Sentara HealthcareNorfolkVirginia23507-

Find similar trials in Stanford, CA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Stanford University· Stanford, CAMedstar Washington Hospital· Washington D.C., DCUniversity of Florida Health Shands Hospital· Gainesville, FLMayo Clinic· Jacksonville, FLAdventHealth Orlando· Orlando, FLLutheran Hospital· Fort Wayne, IN

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