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NCT01966458 · ClinicalTrials.gov registry record · NA
A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)
A NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- NA
- Development phase
- 494
- Enrollment target
NCT01966458: Completed NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT01966458 is a NA study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 494 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01966458, a NA study, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- NA
- Development phase
- 494 participants
- Enrollment target
Study Summary
This is a prospective, randomized, controlled, unblinded, multi-center evaluation of safety and efficacy in patients implanted with a HeartWare® HVAD who receive improved blood pressure management. Subjects have chronic Stage D or 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 is the percent of participants at 12 months on the originally implanted device with neurologic injury, defined as a stroke with Modified Rankin Scale (MRS) \> 0 at 24-weeks post-stroke, or a transient ischemic attack (TIA), or a spinal cord infarction (SCI). 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.
Interventions
- DEVICE Control LVAD
- DEVICE HeartWare® VAS (HVAD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 494 participants |
| Start Date | 2013-10 |
| Est. Completion | 2020-08 |
| Phase | NA |
What the finished NCT01966458 record still lists
NCT01966458 is an interventional study that assigns participants to a tested intervention. The registered 494 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 (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Control LVAD is the first listed.
NCT01966458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01966458 about?
NCT01966458 is a clinical study titled "A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)". This is a prospective, randomized, controlled, unblinded, multi-center evaluation of safety and efficacy in patients implanted with a HeartWare® HVAD who receive improved blood pressure management. Subjects have chronic Stage D or NYHA Class IIIB/IV left ventricular failure who have received and fai...
What is the current status of trial NCT01966458?
This trial is currently completed. It is a NA study. The enrollment target is 494 participants. The study started on 2013-10. Estimated completion is 2020-08.
What interventions are being tested in trial NCT01966458?
The interventions under investigation include: Control LVAD (DEVICE), HeartWare® VAS (HVAD) (DEVICE).
Who is sponsoring clinical trial NCT01966458?
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 NCT01966458's enrollment target sits among peer trials
494 213th of 2000 higher than 1,788 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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