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International EXPAND Heart Pivotal Trial (EXPANDHeart)

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ClinicalTrials.gov Identifier: NCT02323321
Recruitment Status : Active, not recruiting
First Posted : December 23, 2014
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
TransMedics

Brief Summary:
To evaluate the effectiveness of the OCS™ Heart to recruit, preserve and assess donor hearts that may not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation

Condition or disease Intervention/treatment Phase
Heart Transplant Device: Preservation of Hearts for Transplantation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation (EXPAND Heart Trial)
Study Start Date : September 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OCS Preservation
OCS Preservation and Assessment
Device: Preservation of Hearts for Transplantation
Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation




Primary Outcome Measures :
  1. A composite endpoint of patient survival at Day-30 post transplant and absence of severe primary heart graft dysfunction in the first 24 hours post-transplantation [ Time Frame: 30 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Registered male or female primary Heart transplant candidate
  • Age ≥18 years old

Exclusion Criteria:

  • Prior solid organ or bone marrow transplant
  • Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
  • Multi-organ transplant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323321


Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90211
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
TransMedics
Investigators
Principal Investigator: Fardad Esmailian, MD Cedars-Sinai Medical Center
Principal Investigator: Abbas Ardehali, MD University of California Medical Center, Los Angeles
Principal Investigator: Jon Kobashigawa, MD Cedars-Sinai Medical Center
Principal Investigator: Frank Pagani, MD University of Michigan
Principal Investigator: Keith Aaronson, MD University of Michigan
Principal Investigator: Carmelo Milano, MD Duke Medical Center
Principal Investigator: Jacob Schroder, MD Duke Medical Center
Principal Investigator: Jason Smith, MD University of Washington
Principal Investigator: Martin Strueber, MD Spectrum Health, Grand Rapids
Principal Investigator: Asghar Khaghani, MD Spectrum Health, Grand Rapids
Principal Investigator: Kenneth Liao, MD University of Minnesota Medical Center
Principal Investigator: David D'Alessandro, MD Massachusetts General Hospital
Principal Investigator: Ashish Shah, MD Vanderbilt University Medical Center

Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT02323321     History of Changes
Other Study ID Numbers: OCS-CAR-012014
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: April 2018

Keywords provided by TransMedics:
heart transplant
heart preservation
beating heart transplant