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NCT00855712 · ClinicalTrials.gov registry record · NA
Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation
A NA study of Heart Failure, sponsored by TransMedics.
- Completed
- Registry status
- NA
- Development phase
- 128
- Enrollment target
- 11
- Study locations
NCT00855712 is a NA study of Heart Failure that has completed, run by TransMedics. The registered enrollment target is 128 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (94% lower). The trial reports 11 study locations across 7 states.
The verdict
NCT00855712, a NA study of Heart Failure, has completed, sponsored by TransMedics.
- COMPLETED
- Registry status
- NA
- Development phase
- 128 participants
- Enrollment target
- 11
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2009-03 |
| Est. Completion | 2013-11 |
| Phase | NA |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (94% lower). The listed sponsor is TransMedics, which has 23 total studies on file at ClinicalTrials.gov.
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.
NCT00855712 reports 11 study locations spanning 7 distinct geographic areas - top geographies include Other, California, Indiana.
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.
What interventions are being tested in trial NCT00855712?
The interventions under investigation include: Organ Care System (DEVICE), Cold Cardioplegia Solution (DEVICE).
Who is sponsoring clinical trial NCT00855712?
This trial is sponsored by TransMedics, which has 23 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.