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NCT03835754 · ClinicalTrials.gov registry record · NA

Heart EXPAND Continued Access Protocol

A NA study of Heart Transplant, sponsored by TransMedics.

Completed
Registry status
NA
Development phase
75
Enrollment target
12
Study locations

NCT03835754 is a NA study of Heart Transplant that has completed, run by TransMedics. The registered enrollment target is 75 participants, below the 8,524-participant average among 12 other Heart Transplant trials with a reported enrollment target (99% lower). The trial reports 12 study locations across 11 states.

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The verdict

NCT03835754, a NA study of Heart Transplant, has completed, sponsored by TransMedics.

COMPLETED
Registry status
NA
Development phase
75 participants
Enrollment target
12
Study locations

Study Summary

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.

Conditions Studied

Heart Transplant

Interventions

  • DEVICE OCS Heart System

Study Locations (12)

California

  • Cedars-Sinai - Los Angeles
  • Stanford University - Palo Alto

Connecticut

  • Yale New Haven Hospital - New Haven

Florida

  • AdventHealth Orlando - Orlando

Indiana

  • St. Vincent Cardiovascular Research Institute - Indianapolis

Massachusetts

  • Massachusetts General Hospital - Boston

Minnesota

  • Minneapolis Heart Institute - Minneapolis

New York

  • Nyph/Cumc - New York

North Carolina

  • Duke University - Durham

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2019-04-17
Est. Completion 2022-08-12
Phase NA

Sponsor

TransMedics

23 total trials

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What the Registry Record Tells You About NCT03835754

The ClinicalTrials.gov registry entry for NCT03835754 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 8,524-participant average among 12 other Heart Transplant trials with a reported enrollment target (99% lower). The listed sponsor is TransMedics, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Heart Transplant appearing as the primary indexed condition, and to 1 intervention - of which OCS Heart System is the first listed.

NCT03835754 reports 12 study locations spanning 11 distinct geographic areas - top geographies include California, Connecticut, Florida.

Frequently Asked Questions

What is clinical trial NCT03835754 about?

NCT03835754 is a clinical study titled "Heart EXPAND Continued Access Protocol". 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.

What is the current status of trial NCT03835754?

This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2019-04-17. Estimated completion is 2022-08-12.

What conditions does trial NCT03835754 study?

This clinical trial studies the following conditions: Heart Transplant.

What interventions are being tested in trial NCT03835754?

The interventions under investigation include: OCS Heart System (DEVICE).

Who is sponsoring clinical trial NCT03835754?

This trial is sponsored by TransMedics, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03835754 being conducted?

This trial has 12 study locations across California, Connecticut, Florida, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.