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International EXPAND Heart Pivotal Trial (EXPANDHeart)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02323321
Recruitment Status : Completed
First Posted : December 23, 2014
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
TransMedics

Tracking Information
First Submitted Date  ICMJE December 18, 2014
First Posted Date  ICMJE December 23, 2014
Last Update Posted Date December 21, 2020
Actual Study Start Date  ICMJE September 16, 2015
Actual Primary Completion Date April 25, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE International EXPAND Heart Pivotal Trial
Official Title  ICMJE 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)
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Transplant
Intervention  ICMJE Device: Preservation of Hearts for Transplantation
Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation
Study Arms  ICMJE Experimental: OCS Preservation
OCS Preservation and Assessment
Intervention: Device: Preservation of Hearts for Transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2014)
75
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2, 2019
Actual Primary Completion Date April 25, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02323321
Other Study ID Numbers  ICMJE OCS-CAR-012014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TransMedics
Study Sponsor  ICMJE TransMedics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account TransMedics
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP