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NCT00751972 · ClinicalTrials.gov registry record · NA
Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure
A NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- NA
- Development phase
- 140
- Enrollment target
NCT00751972: Completed NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT00751972 is a NA study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 140 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00751972, a NA study, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death. The primary endpoint is survival at 180 days which is defined as alive on the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. Patient must survive 60 days post-explant for recovery to be considered successful. Secondary endpoints include: * Overall survival * Incidence of all serious adverse events, neurocognitive status and unanticipated adverse device effects. * Incidence of all device failures and device malfunctions * Quality of Life improvement, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQoL EQ-5D * Functional status improvement, as measured by the New York Heart Association (NYHA) and 6-minute walk The HeartWare® LVAD System was approved by the US FDA on November 20, 2012 as a bridge to cardiac transplantation (reference PMA P100047). Patients enrolled into this study will be followed to an outcome at six months, and then patients will receive continued follow-up in a separate study.
Primary Outcome
The primary endpoint is success at 180 days which is defined as alive on the originally implanted HeartWare® LVAD or transplanted or explanted for recovery. A patient must survive 60 days post-explant for recovery to be considered successful.
Interventions
- DEVICE HeartWare® VAS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2008-08 |
| Est. Completion | 2013-08 |
| Phase | NA |
What the finished NCT00751972 record still lists
NCT00751972 is an interventional study that assigns participants to a tested intervention. The registered 140 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 (90% lower).
The record links to 0 conditions, and to 1 intervention - of which HeartWare® VAS is the first listed.
NCT00751972 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00751972 about?
NCT00751972 is a clinical study titled "Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure". The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death. The primary endpoint is survival at 180 days which is defined as alive on the originally implan...
What is the current status of trial NCT00751972?
This trial is currently completed. It is a NA study. The enrollment target is 140 participants. The study started on 2008-08. Estimated completion is 2013-08.
What interventions are being tested in trial NCT00751972?
The interventions under investigation include: HeartWare® VAS (DEVICE).
Who is sponsoring clinical trial NCT00751972?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00751972's enrollment target sits among peer trials
140 713th of 2000 higher than 1,281 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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