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International EXPAND Heart Pivotal Trial

NCT02323321 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-01-17

Study results available
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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

Conditions

  • Heart Transplant

Interventions

DEVICE

Preservation of Hearts for Transplantation

Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation

Sponsors & Collaborators

  • TransMedics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-16
Primary Completion
2018-04-25
Completion
2019-03-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02323321 on ClinicalTrials.gov