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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 is a NA study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 494 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01966458
The ClinicalTrials.gov registry entry for NCT01966458 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 494 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 2 interventions - of which Control LVAD is the first listed.
NCT01966458 reports 0 study locations.
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.
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