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NCT01166347 · ClinicalTrials.gov registry record · NA
The HeartWare™ Ventricular Assist System as Destination Therapy of Advanced Heart Failure: the ENDURANCE Trial
A NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- NA
- Development phase
- 451
- Enrollment target
NCT01166347: Completed NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT01166347 is a NA study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 451 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01166347, a NA study, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- NA
- Development phase
- 451 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and effectiveness of the HeartWare Ventricular Assist System in patients with chronic Stage D/ New York Heart Association (NYHA) Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.
Primary Outcome
The primary endpoint of the trial is stroke-free survival at two years, defined as alive on the originally implanted device, electively transplanted or explanted due to patient recovery and free from disabling stroke (Modified Rankin Scale \>=4). The Modified Rankin Scale is scored from 0 to 6, where 0 indicates an absence of symptoms and 6 indicates death. A score of 4 or higher indicates moderately severe or greater disability. Weibull model estimates of survival probability (shown as a percen
Interventions
- DEVICE HeartWare® VAS
- DEVICE Control LVAD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 451 participants |
| Start Date | 2010-08 |
| Est. Completion | 2017-05 |
| Phase | NA |
What the finished NCT01166347 record still lists
NCT01166347 is an interventional study that assigns participants to a tested intervention. The registered 451 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 (68% lower).
The record links to 0 conditions, and to 2 interventions - of which HeartWare® VAS is the first listed.
NCT01166347 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01166347 about?
NCT01166347 is a clinical study titled "The HeartWare™ Ventricular Assist System as Destination Therapy of Advanced Heart Failure: the ENDURANCE Trial". The purpose of this study is to determine the safety and effectiveness of the HeartWare Ventricular Assist System in patients with chronic Stage D/ New York Heart Association (NYHA) Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible fo...
What is the current status of trial NCT01166347?
This trial is currently completed. It is a NA study. The enrollment target is 451 participants. The study started on 2010-08. Estimated completion is 2017-05.
What interventions are being tested in trial NCT01166347?
The interventions under investigation include: HeartWare® VAS (DEVICE), Control LVAD (DEVICE).
Who is sponsoring clinical trial NCT01166347?
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 NCT01166347's enrollment target sits among peer trials
451 225th of 2000 higher than 1,776 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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