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COMPLETED NA

Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation

NCT00855712 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of the study is to compare survival of both patients and newly transplanted hearts following heart transplantation among patients who were transplanted with donated hearts preserved on ice and those who were transplanted with donated hearts using the Organ Care System (OCS). The Organ care system preserves the hearts in a warm blood perfused beating state. The study also compares the number of rejection episodes, heart related adverse events, ICU time, and ventilation time between the two groups. The study is considered a success if survival in the OCS group was not inferior to the ice group.

Conditions Studied

Interventions

  • DEVICE Organ Care System
  • DEVICE Cold Cardioplegia Solution

Study Locations (11)

Other

  • Hospitalier Pitie-Salpetriere — Paris
  • Azienda Ospedaliera S. Maria della Misericordia — Udine
  • Papworth Hospital — Cambridge
  • Harefield Hospital — London

California

  • UCLA Medical Center — Los Angeles
  • Cedars-Sinai Medical Center — Los Angeles

Indiana

  • Indiana University — Indianapolis

Massachusetts

  • Massachusetts General Hospital — Boston

New Jersey

  • Newark Beth Israel Medical Center — Newark

New York

  • Columbia University Medical Center — New York

Ohio

  • Cleveland Clinic — Cleveland

Trial Details

FieldValue
Enrollment Target 128 participants
Start Date 2009-03
Est. Completion 2013-11
Phase NA

Sponsor

TransMedics

16 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00855712

The ClinicalTrials.gov registry entry for NCT00855712 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TransMedics, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 2 interventions — of which Organ Care System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00855712 reports 11 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00855712 about?

NCT00855712 is a clinical study titled "Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation". The purpose of the study is to compare survival of both patients and newly transplanted hearts following heart transplantation among patients who were transplanted with donated hearts preserved on ice and those who were transplanted with donated hearts using the Organ Care System (OCS). The Organ ca...

What is the current status of trial NCT00855712?

This trial is currently completed. It is a NA study. The enrollment target is 128 participants. The study started on 2009-03. Estimated completion is 2013-11.

What conditions does trial NCT00855712 study?

This clinical trial studies the following conditions: Heart Failure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00855712?

The interventions under investigation include: Organ Care System (DEVICE), Cold Cardioplegia Solution (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00855712?

This trial is sponsored by TransMedics, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00855712 being conducted?

This trial has 11 study locations across California, Indiana, Massachusetts, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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