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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 is a NA study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 140 participants.
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.
Interventions
- DEVICE HeartWare® VAS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2008-08 |
| Est. Completion | 2013-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00751972
The ClinicalTrials.gov registry entry for NCT00751972 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiac Rhythm and Heart Failure, which has 115 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HeartWare® VAS is the first listed.
NCT00751972 reports 0 study locations.
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.
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