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NCT00121472 · ClinicalTrials.gov registry record · NA
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation
A NA study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 194
- Enrollment target
NCT00121472: Completed NA study, sponsored by Abbott Medical Devices.
NCT00121472 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 194 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00121472, a NA study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 194 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed for cardiac transplant but are at imminent risk of dying. The HeartMate II LVAS was approved by the US FDA on April 21, 2008, as a bridge to cardiac transplantation (reference PMA P060040). It was approved for commercial distribution in Canada on May 20, 2009 (reference Medical Device Licence #79765). Patients enrolled into the clinical trial will continue to be followed until all have reached a clinical outcome.
Primary Outcome
Survival to cardiac transplantation or 180 days on left ventricular assist system (LVAS) support while remaining listed for cardiac transplantation as United Network for Organ Sharing (UNOS)status 1A or 1B (please refer to www.unos.org for complete definitions of status).
Interventions
- DEVICE Thoratec HeartMate II Left Ventricular Assist System (LVAS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2005-03 |
| Est. Completion | 2010-05 |
| Phase | NA |
What the finished NCT00121472 record still lists
NCT00121472 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Thoratec HeartMate II Left Ventricular Assist System (LVAS) is the first listed.
NCT00121472 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00121472 about?
NCT00121472 is a clinical study titled "Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation". The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed for cardiac transplant but are at imminent risk of dying. The HeartMate...
What is the current status of trial NCT00121472?
This trial is currently completed. It is a NA study. The enrollment target is 194 participants. The study started on 2005-03. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00121472?
The interventions under investigation include: Thoratec HeartMate II Left Ventricular Assist System (LVAS) (DEVICE).
Who is sponsoring clinical trial NCT00121472?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00121472's enrollment target sits among peer trials
194 568th of 2000 higher than 1,432 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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