International EXPAND Heart Pivotal Trial

Not Applicable

Completed

• Conditions: Heart Transplant
• Interventions: Device: Preservation of Hearts for Transplantation

• Registration Number: NCT02323321
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2014-12-18
• Study First Posted: 2014-12-23
• Study Start: 2015-09-16
• Primary Completion: 2018-04-25
• Study Completion: 2019-03-02
• Status Verified: 2019-08
• Results First Submitted: 2024-12-23
• Results First Submitted QC: 2024-12-23
• Last Update Submitted: 2024-12-23
• Results First Posted: 2025-01-17
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OCS Preservation	Preservation of Hearts for Transplantation	OCS Preservation and Assessment

Primary Outcome Measures

Name	Time	Method
Patient Survival at Day-30 Post Transplant and Absence of Severe Primary Heart Graft Dysfunction in the First 24 Hours Post-transplantation	30 Days	A composite endpoint of patient survival at Day-30 post-transplant and absence of severe heart primary graft dysfunction (PGD) (left or right ventricle)) in the first 24 hours post-transplantation.

Trial Locations

Locations (11)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Minneapolis Heart Institute; 🇺🇸 Minneapolis, Minnesota, United States

University of Minnesota Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States

Mount Sinai; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States