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NCT07145515 · ClinicalTrials.gov registry record · NA

Enhancing Heart Allograft Function With the OCS Heart System Trial

A NA study of Heart Transplant, sponsored by TransMedics.

Recruiting
Registry status
NA
Development phase
655
Enrollment target
8
Study locations

NCT07145515 is a NA study of Heart Transplant that is actively recruiting participants, run by TransMedics. The registered enrollment target is 655 participants, below the 8,475-participant average among 12 other Heart Transplant trials with a reported enrollment target (92% lower). The trial reports 8 study locations across 6 states.

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The verdict

NCT07145515, a NA study of Heart Transplant, is actively recruiting participants, sponsored by TransMedics.

RECRUITING
Registry status
NA
Development phase
655 participants
Enrollment target
8
Study locations

Study Summary

This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Cold Storage (SCS) in DBD heart transplantation to potentially demonstrate superiority.

Conditions Studied

Heart Transplant

Interventions

  • DEVICE OCS Heart
  • OTHER Static Cold Storage (SCS)

Study Locations (8)

New York

  • Mount Sinai - New York
  • Columbia University Irving Medical Center/ New York Presbyterian Hospital - New York
  • Westchester Medical Center - Valhalla

California

  • University of California San Francisco - San Francisco

Florida

  • Tampa General Hospital - Tampa

Massachusetts

  • Massachusetts General Hospital - Boston

North Carolina

  • Duke University - Durham

Texas

  • Baylor Scott and White - Dallas

Trial Details

FieldValue
Enrollment Target 655 participants
Start Date 2026-01
Est. Completion 2027-07-30
Phase NA

Sponsor

TransMedics

23 total trials

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What the Registry Record Tells You About NCT07145515

The ClinicalTrials.gov registry entry for NCT07145515 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 655 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 8,475-participant average among 12 other Heart Transplant trials with a reported enrollment target (92% 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 2 interventions - of which OCS Heart is the first listed.

NCT07145515 reports 8 study locations spanning 6 distinct geographic areas - top geographies include New York, California, Florida.

Frequently Asked Questions

What is clinical trial NCT07145515 about?

NCT07145515 is a clinical study titled "Enhancing Heart Allograft Function With the OCS Heart System Trial". This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Co...

What is the current status of trial NCT07145515?

This trial is currently recruiting. It is a NA study. The enrollment target is 655 participants. The study started on 2026-01. Estimated completion is 2027-07-30.

What conditions does trial NCT07145515 study?

This clinical trial studies the following conditions: Heart Transplant.

What interventions are being tested in trial NCT07145515?

The interventions under investigation include: OCS Heart (DEVICE), Static Cold Storage (SCS) (OTHER).

Who is sponsoring clinical trial NCT07145515?

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

Where is trial NCT07145515 being conducted?

This trial has 8 study locations across California, Florida, Massachusetts, New York, North Carolina. 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.