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Completed Not applicable Interventional Results available

Heart EXPAND Continued Access Protocol

ClinicalTrials.gov ID: NCT03835754

Public ClinicalTrials.gov record NCT03835754. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 9:37 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Heart Expand Continued Access Protocol

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The OCS™ Heart System will be used to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria for transplantation in this continued access protocol.

Study identification

NCT ID
NCT03835754
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
TransMedics
Industry
Enrollment
75 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 17, 2019 (Actual)
Primary completion
Sep 15, 2021 (Actual)
Completion
Aug 12, 2022 (Actual)
Last update posted
Jan 17, 2025

2019 – 2022

United States locations

U.S. sites
12
U.S. states
11
U.S. cities
12
Facility City State ZIP Site status
Cedars-Sinai Los Angeles California 90211 —
Stanford University Palo Alto California 94304 —
Yale New Haven Hospital New Haven Connecticut 06510 —
AdventHealth Orlando Orlando Florida 32803 —
St. Vincent Cardiovascular Research Institute Indianapolis Indiana 46260 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Minneapolis Heart Institute Minneapolis Minnesota 55407 —
Nyph/Cumc New York New York 10032 —
Duke University Durham North Carolina 27710 —
Ohio State University Columbus Ohio 43210 —
Vanderbilt Medical Center Nashville Tennessee 37232 —
University of Washington Medical Center Seattle Washington 98195 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03835754, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 17, 2025 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03835754 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →