OCS DCD Heart + CAP Continued Follow-Up

NCT ID: NCT05741723

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

276 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-26

Study Completion Date

2026-10-31

Brief Summary

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The objective of this post-approval study is to evaluate long-term outcomes of patients enrolled in the OCS DCD Heart and OCS DCD Heart CAP studies.

Detailed Description

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Conditions

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Heart Transplant

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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OCS Heart

Transplanted with OCS preserved heart.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients transplanted in the OCS DCD Heart Trial and OCS DCD Heart CAP trials.
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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University of California San Diago

La Jolla, California, United States

Site Status

Stanford University

Palo Alto, California, United States

Site Status

Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status

Mayo Clinic Florida

Jacksonville, Florida, United States

Site Status

AdventHealth Orlando

Orlando, Florida, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Northwestern Medicine

Chicago, Illinois, United States

Site Status

St. Vincent Cardiovascular Research Institute

Indianapolis, Indiana, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Minneapolis Heart Institute

Minneapolis, Minnesota, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Nyph/Cumc

New York, New York, United States

Site Status

Montefiore

The Bronx, New York, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Vanderbilt Medical Center

Nashville, Tennessee, United States

Site Status

Sentara

Norfolk, Virginia, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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OCS-HEART-03-PAS

Identifier Type: -

Identifier Source: org_study_id

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