International EXPAND Heart Pivotal Trial

NCT ID: NCT02323321

Last Updated: 2025-01-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-16

Study Completion Date

2019-03-02

Brief Summary

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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

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Conditions

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Heart Transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OCS Preservation

OCS Preservation and Assessment

Group Type EXPERIMENTAL

Preservation of Hearts for Transplantation

Intervention Type DEVICE

Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation

Interventions

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Preservation of Hearts for Transplantation

Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TransMedics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Spectrum Health

Grand Rapids, Michigan, United States

Site Status

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

Site Status

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Site Status

Mount Sinai

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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OCS-CAR-012014

Identifier Type: -

Identifier Source: org_study_id

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