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International EXPAND Heart Pivotal Trial (EXPANDHeart)

This study is currently recruiting participants.
Verified March 2016 by TransMedics
Sponsor:
ClinicalTrials.gov Identifier:
NCT02323321
First Posted: December 23, 2014
Last Update Posted: March 30, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
TransMedics
  Purpose
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 Intervention Phase
Heart Transplant Device: Preservation of Hearts for Transplantation Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by TransMedics:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 75
Study Start Date: September 2015
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OCS Preservation
OCS Preservation and Assessment
Device: Preservation of Hearts for Transplantation
Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Waleed H Hassanein, MD 978-552-0901 whassanein@transmedics.com
Contact: Tamer I Khayal, MD 978-522-0901 tkhayal@transmedics.com

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90211
Contact: Fardad Esmailian, MD    310-423-3851    fardad.esmailian@cshs.org   
Principal Investigator: Fardad Esmailian, MD         
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98105
Contact: Jason Smith, MD    206-598-3636    Jwsmith@uw.edu   
Principal Investigator: Jason Smith, MD         
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
  More Information

Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT02323321     History of Changes
Other Study ID Numbers: OCS-CAR-012014
First Submitted: December 18, 2014
First Posted: December 23, 2014
Last Update Posted: March 30, 2016
Last Verified: March 2016

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